Quality & Regulatory Compliance, Auditor, IT & Cyber Security, Cloud Solutions, CSV & Medical Device Software Validation, Agile Business Analyst SAP
Aktualisiert am 21.03.2023
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 21.03.2023
Verfügbar zu: 50%
davon vor Ort: 30%
Digital Health
Quality Management
Computer System Validation
ISO 27001
DIN EN ISO 13485
IEC 62304
Auditor
Requirement Engineer
Business Analyst
Business Process Modeling
21 CFR Part 820
Agile Softwareentwicklung
Software as a Medical Device SaMD
ISO 14971
Software Lifecycle
IT Security nach BSI
GAMP
Biotechnology
GMP
21 CFR
cloud transformation
SAP HANA
IaaS
English
business fluent
German
native

Einsatzorte

Einsatzorte

Frankfurt (+50km) Berlin (+20km) Hamburg-Mitte (+20km) Basel (+10km) Zürich (+10km)
Deutschland, Schweiz, Österreich
auch weltweite Reisen und Einsatz möglich
möglich

Projekte

Projekte

1 Jahr 1 Monat
2023-02 - heute

Service Delivery and direct report

IT Business Partner for IT Transformation
IT Business Partner for IT Transformation

  • Large holistic transformation and change program in which different system landscapes (SAP, ERP, Salesforce from different countries) are to be unified (considering local regulations)
  • The project is in the area of IPG (Integrated Package Gas) and Supply Chain
  • Create target/actual analysis of the above-mentioned system landscapes (participation in workshops, documentation, develop strategies, sell ideas)
  • Independent negotiations with department heads and other management levels for the possible implementation of topics in the Integrated Package Gas area
  • Independent definition of IT-technical components and requirements
  • Advice on compliance with the implementation and deadlines for topics arising from the target/actual analysis
  • Advising staff on the relevant work tasks and processes and change management

gladly on request
Düsseldorf and worldwide
1 Jahr 5 Monate
2022-10 - heute

Implementation of a digital health platform for product innovation

Strategy Consultant & Project Lead ? Digital Transformation
Strategy Consultant & Project Lead ? Digital Transformation

Service Delivery and direct report to Head of Innovation and Development

  • Creation of URS document for DHP including Regulatory & quality requirements/controls, SLCM & validation requirements, Data protection & security requirements
  • Creation of Architecture Handbook for DHP (build on Cloud Computing/Xaas)
  • Manage and coordinate DHP Design Workshop
  • Lead and coordinate Supplier Selection process for DHP/ Cloud Services, pre-selection of suitable suppliers based on created supplier questionnaire,
  • Audit Supplier regarding ISO 13485 and IEC 62304 as well as IT & Cyber Security (Cloud Security Alliance) and System Lifecycle processes (BSI Compendium, ISO 27001)
  • Run Supplier Demos and perform Gap Assessment with recommendations for contract negotiation
Möller Medical
Fulda/DE
2 Jahre 2 Monate
2022-01 - heute

Service Delivery and direct report

CSV/ Quality & Compliance Strategy Consultant for Digital Manufacturing (MES)
CSV/ Quality & Compliance Strategy Consultant for Digital Manufacturing (MES)

Service Delivery and direct report to Head of IT Compliance & GMP Quality

  • Global Rollout of MES to all local production sites (Pilot Sites: Poland, Brazil, Mexico, Thailand)
  • Establish Global and local Validation Strategy for Core MES (Traksys & Promas plus Interfaces to Movement Controller, LIMS, Siemens S7 etc.)
  • Creation of Validation Master Plan incl. CSV Templates for Validation Plan & Report, Supplier Audit, Risk Management (based on new GAMP 5 2nd edition, FDA CSA and Agile methods)
  • Accompany and perform Validation activities and documentation, run CSV MVP1 in Poland and Update of Validation Strategy and Templates
  • Conduct IT Supplier Audits
  • Manage Retro & Lessons Learned Workshop with all regulated production sites
Beiersdorf AG
Hamburg and worldwide
3 Jahre 2 Monate
2021-01 - heute

Building a Lean & Agile Quality Management System

Quality Manager & Auditor, Prozess Manager ISO 9001 Audits Prozessmodelierung ...
Quality Manager & Auditor, Prozess Manager
ISO 9001 Audits Prozessmodelierung Digital Asset Management
Basel
1 Monat
2023-02 - 2023-02

Digital Health Innovations

CEO & Founder, Quality & Compliance Manager, Auditor
CEO & Founder, Quality & Compliance Manager, Auditor

  • Quality & Compliance Strategy Consultant for Digital Health Innovations
    • Combination products (BioTech/MedTech)
    • Software as a Medical Device, Digital Health Apps, Digital Therapeutics, DIGA
    • Exoskeleton, Software Apps and Digital Health Platforms
    • Health Information Platforms for RWD, Genetic/DNA data, R&D
  • Service Delivery and direct report to CEOs, CIOs, Global Quality & Regulatory Heads
    • Audit and Assessment of regulatory landscape for Product Classification and Development, define scope technical documentation to achieve conformity
    • Encourage and develop V&V strategy for Product Development 62304/82304 and achieve CE Mark or market access (EU/US)
    • Concept & Design of QMS (Biotech, MedTech) and achieve certification (EMA, FDA, Notified Body)
    • Build Cloud & Data Repository Strategy for Digital Health Platform as part of Medical Device or SaMD
    • Build IT Operating Model (ITIL, IT4IT, SAFe DevOPs, Scrum) including Computer System Validation GAMP 5, Annex 11, Part 11, IT & Cyber Security ISO 27001, BSI, ISACA,
    • Implement Supplier Management & Governance Model
    • Design, coordinate and moderate Workshops ? onsite and remote, using interactive digital presentations and moderation tools (Teams, Zoom, Webex, MIRO, MURAL, Mentimeter, Asana, JIRA, Confluence etc.)

gladly on request
Basel/CH
11 Monate
2022-02 - 2022-12

Digitalization new iNeST Manufacturing Facility

Senior Project Manager & Specialist Digitalization new iNeST Manufacturing Facility (Next Generation Immunotherapy)
Senior Project Manager & Specialist Digitalization new iNeST Manufacturing Facility (Next Generation Immunotherapy)

Service Delivery and direct report to Head of Global Digitalization Projects & Site Head

  • Develop, establish and drive MES Core Strategy and rollout concept for manufacturing sites (Release & Change Management, Requirement Management within Azure Devops, Validation Strategy)
  • Lead Fit/Gap Workshops and support BNT Experts in defining/ prioritizing potential software gaps
  • Manage delivery of 5 MBR blueprints according to process specification for review & test for Pilot Facility. (MBRs, GMBRs, ESP, Master data)
  • Consult MBR specification creation, Consult Label design and configuration in PAS-X for ca. 10 labels according to specification.
  • Establish continuous improvement of MBR Design following process & interface clarification.
  • Consult completion of qualified installation of system environment
  • Build and enroll Project Governance Model
  • Lead Project Management (Project Plan, Risks, Budget, Resources)
  • Facilitate and engage stakeholders from PM, IT, QA, CSV and Business
  • Design, coordinate and moderate Workshops for MES System Implementation (Fit-Gap-Analysis, Blueprint Design, Verification Strategy etc.)

BioNTech
Mainz/DE
11 Monate
2022-02 - 2022-12

Cloud Transformation Program

TECH Senior Cyber Risk Consultant for Cloud Transformation Program
TECH Senior Cyber Risk Consultant for Cloud Transformation Program

Service Delivery and direct report to Head of Global Digitalization Projects

  • Plan, coordinate and control the software development within RAITT to check that all software packages have the needed compliance requirements implemented:
    • Definition of low-level security design
    • Implementing of the new Security, Compliance, Risk and Data Protection controls
    • Independent coordination of technical units within the scope of analysis and implementation of the above-mentioned new functionalities
    • Create a low-level specification document for new controls to be developed within RAITT
    • Project management for software development monitoring that the controls mentioned above are implemented correctly
Telefónica
Germany
1 Jahr 8 Monate
2021-05 - 2022-12

Cloud Transformation Program

Quality & Compliance Strategy Consultant 
Quality & Compliance Strategy Consultant 

  • Cloud Transformation Program with focus on CSV & IT Security Strategy (Azure Cloud, XaaS, SAP 4HANA)
  • Service Delivery and direct report to Head of IT Compliance & GMP Quality
    • Improvement and update of BSS/BDF Validation Strategy Incl. CSV Policy, Templates for Validation Plan & Report, Supplier Management, Risk Management (based on new GAMP 5 2nd edition and FDA CSA)
    • Encourage and develop global Strategy for Qualification and Validation of Cloud Solutions (Iaas, Paas, SaaS, Kubernetes) used for medicinal and GxP-relevant data
    • Transition from on premise to Cloud Strategy (Azure, SAP 4HANA)
    • Scope: Computer System Validation GAMP 5, Annex 11, Part 11, IT & Cyber Security ISO 27001, BSI, ISACA
    • Conception Validation Strategy Incl. Policy, Templates for Validation Plan & Report, Supplier Management, Risk Management

Beiersdorf AG
Hamburg
1 Jahr
2021-12 - 2022-11

Consulting services for the preparation

Strategy Consultant for Digital Health App & SaMD, Service Delivery and direct report to Global Director, Devices and Instrumentation
Strategy Consultant for Digital Health App & SaMD, Service Delivery and direct report to Global Director, Devices and Instrumentation

Consulting services for the preparation of technical documentation for EKF Link

  • New Product Release of POC data management system EKF Link
  • IVDR Update
  • Concept SLCM with Supplier
  • Update QMS 13485 with IEC 62304/82304
EKF Diagnostics, Barleben/DE
2 Jahre 3 Monate
2019-10 - 2021-12

Agile Computer System Validation

Quality and Compliance/ CSV Strategy Consultant
Quality and Compliance/ CSV Strategy Consultant

Service Delivery and direct report to Quality Assurance and Regulatory Affairs Management

  • Giving Strategy and Advice to establish a Software Development Framework for Agile Software Development under CSV based on Scrum Methodology within JIRA and Confluence
  • Conception and Realization of Validation Strategy for the Development and Implementation of local Implementation of IT Systems for a Unified Lab Management software (BIOVIA) within the Research & Development Center of FKSB
Fresenius Kabi SwissBioSimiliar
Eysin/CH
1 Jahr 9 Monate
2020-02 - 2021-10

Digital Health Systems, Software as a Medical Device

Quality & Compliance Strategy Consultant 
Quality & Compliance Strategy Consultant 

  • Digital Health Systems, Software as a Medical Device (SaMD) and Digital Health Platform
  • Service Delivery and direct report to Project Management, Quality Assurance and Regulatory Affairs
    • Encourage and develop global Strategy for Qualification and Validation of Digital Health Platforms IoT) used for medicinal and GxP-relevant data (Iaas, PaaS, Saas, Kubernetes), ISO 13485 & ISO 27001
    • CSV/ Validation Responsible during Supplier Assessment for PaaS
    • Validation Management as Project Quality Manager for Digital Health Platforms
Novartis Pharma, TRD and NBS
Basel/CH, Dublin/IR and worldwide
6 Monate
2021-03 - 2021-08

Digital Health Systems, Software as a Medical Device

Quality & Compliance Strategy Consultant
Quality & Compliance Strategy Consultant

  • Digital Health Systems, Software as a Medical Device (SaMD) and Digital Health Platform
  • Service Delivery and direct report to Project Management, Quality Assurance and Regulatory Affair
    • Encourage and develop global Strategy for Qualification and Validation of Digital Health Platforms used for medicinal and GxP-relevant data (PaaS, Kubernetes)
    • CSV/ Validation Responsible during Supplier Assessment for PaaS
    • Validation Management as Project Quality Manager for Digital Health Platforms
Novartis Pharma, TRD and NBS
Basel/CH, Dublin/IR and worldwide
5 Monate
2021-03 - 2021-07

Cloud CSV & IT Security Strategy (Azure, SAP, RIMS)

Quality & Compliance Strategy Consultant 
Quality & Compliance Strategy Consultant 

Service Delivery and direct report to Head of IT

  • Encourage and develop global Strategy for Qualification and Validation of Cloud Solutions (Iaas, Paas, SaaS, Kubernetes) used for medicinal and GxP-relevant data
  • Scope: Computer System Validation GAMP 5, Annex 11, Part 11, IT & Cyber Security ISO 27001, BSI, ISACA
  • Conception Validation Strategy incl. Policy, Templates for Validation Plan & Report, Supplier Management, Risk Management
Nordmark Pharma
Hamburg
11 Monate
2019-07 - 2020-05

Development Software as a Medical Device (SaMD)

Project Manager
Project Manager

Service Delivery and direct report to Quality Head and Program Lead

  • Project Management within Global Program for Software Development and Launch of Software as a Medical Device (SaMD) used for Diabetes Care
  • Giving Strategy and Advice to establish and improve Corporate Framework within existing QMS 13485 for Software Development, Verification and Validation of Health Apps, fulfilling new MDR requirements
  • Quality Management support to extend QMS 13485 with relevant procedures and working instructions for Regulatory Compliance with new Medical Device Regulation (MDR) regarding SaMD, transfer to class 2a and 2b
  • Business Process Design within SharePoint, Confluence, JIRA and other Tools for usage as a regulated and validated QMs, Lifecyle and Document Management System (Workflows, Templates, Technical File, Electronic Records and Signatures)
Sanofi Aventis
Frankfurt/DE and worldwide
4 Monate
2019-11 - 2020-02

Transfer Software as a Medical Device (SaMD) to Class II (MDR Update)

Quality & Risk Manager
Quality & Risk Manager

Service Delivery and direct report to Quality Assurance and Product Owner

  • Transfer of SaMD for Parenteral Nutrition Management within hospitals in Europe from class I to class IIa (new MDR)
  • Quality Management support to extend QMS 13485 with relevant procedures and working instructions for Regulatory Compliance with new Medical Device Regulation (MDR) regarding SaMD
  • Transfer of SaMD from class I to class IIa (new MDR)
  • Review and Update of Technical Documentation, giving advice to Software Development Team
  • Conduct Risk Assessment for SaMD
Fresenius Kabi Espana
Barcelona/ES
6 Monate
2019-07 - 2019-12

Development Software as a Medical Device (SaMD)

Quality & Risk Manager
Quality & Risk Manager

Service Delivery and direct report to Quality Assurance and Product Owner

  • Risk Manager for SaMD, conducting all levels of risk management according to ISO 14971 (Risk Policy, PHA, FMEA)
  • As Quality Manager: Quality Review and Compliance Check of Technical Documentation, giving advice to Software Development Team (IEC 62304, ISO 13485)

Vifor Pharma
Zürich/CH
2 Jahre 2 Monate
2017-11 - 2019-12

Service Delivery

Global IT Quality and Compliance Strategy Consultant, Program Quality Lead, Senior Business Analyst and Requirements Engineer
Global IT Quality and Compliance Strategy Consultant, Program Quality Lead, Senior Business Analyst and Requirements Engineer

Service Delivery and direct report to Head of Global Quality and Global IT Management

  • Conception and Realization of a Global Competence Center for Computer System Validation to ensure worldwide Quality Assurance and Compliance of gxp-relevant IT systems and projects, including implementation of CSV Knowledge Management and Quality Assurance Unit worldwide
  • Conception and Process Design of One Global IT Architecture Landscape for a validated Global Application Lifecycle Management, integrating all Global IT Systems through harmonized Business Process & Business Requirement Management, System Specification and Test Case Design (using ARIS BPM Tool), including Change Control and Change Impact Analysis
  • CSV/ Software Validation of ARIS BPM Tool to manage all business process/ system changes and validation documentation (URS, FS, RA, Test Scripts) within ARIS (validated Approval workflow without print outs)
  • CSV/ Software Validation of new implementation of Service Now Discovery/ IT Infrastructure
  • CSV/ Software Validation and Quality Assurance of global Archive System in compliance with Data Integrity and EU-DSGVO, creation of business requirements and SOPs/ WIs regarding Data Integrity and ERES regulations
  • CSV/ Software Validation and Quality Assurance, Program Quality Lead of global Cloud Solution
  • CSV/ Software Validation and Quality Assurance, Program Quality Lead for Office 365 corporate Implementation and Global Rollout (Lotus Notes to Office 365), including Data Migration Projects for GxP-relevant IT System to SharePoint or Documentum D2
Fresenius Kabi
worldwide
6 Monate
2019-01 - 2019-06

R&D Laboratory Relocation BioSimiliar

Quality & Compliance Manager/ Auditor for CSV Computer System Validation Software Lifecycle Data Quality ...
Quality & Compliance Manager/ Auditor for CSV
  • Quality Assurance for Computer System Validation of Laboratory Relocation and Integration of Global IT Systems for Document Management (eCTD, eTMF, CTM, eLN)
  • Auditing of Supplier of It Systems
  • Requirement Analysis and Engineering for URS
Documentum D2 Good Laboratory Practice Labware
Computer System Validation Software Lifecycle Data Quality Auditor Data-Migration Software Quality Assurance agiles Projektmanagement Requirement Analyse Conception Bio-Technologie
Fresenius Kabi SwissBioSim
Eysin
1 Jahr 3 Monate
2018-01 - 2019-03

Medical Device Software/ System Development, Validation + Verification Framework for Digital Health Apps

Quality Assurance CSV and Medical Device Software Validation Scrum ISO13485 IEC 62304 ...
Quality Assurance CSV and Medical Device Software Validation

Service Delivery and direct report to Managing Director Digital Lab for Software Development of Medical Device Software and Computerized Systems

Fresenius Kabi Digital Labs GmbH, Berlin

  • Conception and Realization of Software Development Framework for Digital and Mobile Solutions based on Scrum Metholodgy combining regulated Life Cycle Documentation of Medical Device Software Validation and Verification and Computer System Validation
  • Validation Strategy and Management for Digital Health Medical Apps
  • Validation Concept and Management for Software Validation of JIRA Confluence for usage as validated Project and Documentation Software within Digital Lab
  • Quality Management support to implement Quality Management System ISO 134585 and ISO 9001 into Digital Labs (QMS Handbook, Procedures, Internal Audits)
  • Regulatory Compliance within Pharmaceuticals and Medical Device industry (EMA, FDA, PIC/S, ISO, MDD)
  • Quality Risk Management (FMEA)
  • Software Validation and Verification (IEC 62304/82304, GAMP 5), Usability Testing
  • Training and Coaching in regards to Computer System Validation and Regulatory Compliance
  • Stakeholder Management within Fresenius Quality Community
Atlassian Confluence Atlassian JIRA Agile Usability Testing Computer System Validation Application Lifecycle Management FMEA
Scrum ISO13485 IEC 62304 Software Quality Assurance Audit ISO 27001
Fresenius Digital Labs GmbH
Berlin
6 Monate
2018-01 - 2018-06

Building a Global CSV Competence Center

IT Quality and Compliance Strategy Consultant, Senior Business A Computer System Validation Business Process Analysis Business Process Modeling Notation ...
IT Quality and Compliance Strategy Consultant, Senior Business A
  • Conception and Realization of a Global Competence Center for Computer System Validation to ensure worldwide Quality Assurance and Compliance of gxp-relevant IT systems and projects, including im-plementation of CSV Knowledge Management and Quality Assurance Unit worlwide
  • Conception and Process Design of One Global IT Architecture Landscape for a validated Global Application Lifecycle Management, integrating all Global IT Systems through harmonized Business Process & Business Requirement Management, System Specification and Test Case Design (using ARIS BPM Tool), including Change Control and Change Impact Analysis
  • CSV/ Validation of ARIS BPM Tool to manage all business process/ system changes and validation doc-umentation (URS, FS, RA, Test Scripts) within ARIS (validated Approval workflow without print outs)
  • Conception and Realization of CSV Framework and QMS for the new Digital Lab of Frensenius (Digital Healthcare and Mobile and Medical Devices), implementing Confluence as validated Project and Documentation Software
  • CSV/ Validation of new implementation of Service Now Discovery
  • CSV/ Validation of global Archive System in compliance with Data Integrity and EU-DSGVO, creation of business requirements and SOPs/ WIs in regrads to Data Integrity and ERES regulations
ARIS Plattform Atlassian Confluence Documentum D2 SAP ERP SAP SolMan
Computer System Validation Business Process Analysis Business Process Modeling Notation Software Quality Assurance GxP-Compliance Application Lifecycle Management RequirementEngineering Knowledge Management Change Management Qualitäts Management ISO 9001 GAMP
worldwide
2 Jahre
2016-01 - 2017-12

Strategy Consultant Computer System Validation

Global Quality Management, Global Quality and System Compliance GxP-Compliance Audit Application Lifecycle Management ...
Global Quality Management, Global Quality and System Compliance
  • Giving Strategy and Advice to establish a Corporate Framework for Project Governance of Computer System Validation (risk-based approach GAMP5)
  • Ensure the Corporate Framework and corresponding Global Operating Procedures are  fully integrated into Fresenius Kabi Global IT Strategy
  • Ensure that computer system validation strategy is effectively implemented for all GxP systems and that they remain compliant throughout their life-cycle
  • Support the development of compliance standards (e.g. Global Operating Procedures, templates, and training materials) as well as IT project related documents in line with Fresenius quality and regulatory requirements in the respective IT function.
  • Liaise effectively with Quality and IT personnel across Fresenius Kabi as well as other Divisional quality and business functions to ensure that standards and effective processes for governing GxP computerized systems are in place, maintained and opportunities for continuous improvement identified and implemented
  • Support the development and delivery of training relevant for Quality, IT and business functions in the area of computerized systems compliance

Global IT Programs: eDMS, SAP, MES, TRACKWISE, Complaint Handling Tool

Documentum D2 Werum IT Solutions
GxP-Compliance Audit Application Lifecycle Management Qualitätsicherung Knowledge Management Complaint Management Computer System Validation Business Reporting
Fresenius Kabi
Bad Homburg, Germany
3 Monate
2015-10 - 2015-12

IT Quality and Compliance Manager with focus on IT Transition, Information Governance and Risk Management

  • Ensuring that the transition projects and applications are managed in compliance with IGM requirements, e.g. Novartis project management methodology (“ICE”)
  • Validating all project and system life cycle documents in compliance with IGM/ICE and CSV to force the acceptance of transition, developing document management and archiving concept for all audit relevant documents
  • Verify that all project-related tests are conducted according to the project quality plan and in compliance with IGM requirements.
  • Perform quality reviews for audit readiness, identify and document all project observations, gaps and risk with associated mitigation strategies
  • Support the problem solving of project and quality risk and provide quality guidance on GxP regulatory requirements (including, but not limited to 21 CFR Parts 11, 820 and EU GMP Annex 11.)
  • Schedule sessions with Project and Operations Team to drive mitigation actions on gaps and risks
  • Ensure Acceptance Meetings, Knowledge Transfer and Asset identification for project transition
Novartis AG
Basel, Switzerland
11 Monate
2014-12 - 2015-10

Senior IT Business Analyst with focus on Manufacturing and Logistics, IT Service Management

Interim Management at Local IT, Manufacturing and Logistics
Interim Management at Local IT, Manufacturing and Logistics
  • Managing Service Delivery Management: incident, service request and change management processes for IT applications of the integrated IT warehousing, material flow and distribution system environment in PharmOps Switzerland (MES, SAP WM (ERP), GISC Labeling and Material Movement Controller 
  • Support and demand management for the ‘SU Process and Logistics Services’ concerning application operations and projects (e.g. warehouse refurbishment, weighing & dispensing)  
  • ‘Translating’ business and engineering requirements for IT suppliers to realize IT solutions via changes and projects 
  • Development of MS SharePoint Site for Document Management and Knowledge Base for Key Users, delivered Workshops, Trainings and Onboarding Strategy
Novartis AG
Basel, Switzerland
5 Monate
2015-05 - 2015-09

Senior IT Business Analyst with focus on Requirements Engineering and Test Management

Document Management Software Project, Artwork Operations
Document Management Software Project, Artwork Operations
  • Global Implementation of Documentum D2 for Document Management of Regulatory Artworks
  • Identify and create Business User Requirements within Workshops with Key Users to design the expected IT Solution
  • Design of Test Cases (PQ Testing) ensuring coverage of user requirements  
  • Authoring of Test Specifications  
  • Coordinate Test Execution with Subject Matter Experts  
  • Prepare and Conduct pre-go-live and post-go-live/ hypercare sessions taylored for the different end user groups of 800 users worldwide 
Novartis AG
Basel, Switzerland
8 Monate
2014-05 - 2014-12

Business Transformation and Transition Project, Supply Chain Excellence, MRP II Class A

Project Manager with focus on Change and Communication Managemen
Project Manager with focus on Change and Communication Managemen
  • Leading the Transition of Master Data Management and Purchasing from Basel/Switzerland to Hyderabad/India in Pharma External Supply Organization
  • Accompany of NOSSCEE (Novartis Operational Standards for Supply Chain Excellence), Project to establish Global Supply Chain Excellence and KPI Reporting to target a MRP2 Class-A Certification, audited by Oliver Wright Company
  • Direct reports to Head of Supply Chain and Steering Committee: project charter, project plan, project report, status reports,  risk plan including targets, milestones, resources, cost, expenses
  • Business Process Analysis, Gap Analysis and Optimization 
  • Development of value-creation and harmonized processes within all involved functions: Quality, Supply Chain, Sourcing and Finance 
  • Stakeholder Management
  • Change Management, Change Communication 
  • Training Development, Training Coordination 
  • Leading the Transition of Master Data Management and Purchasing from Basel/Switzerland to Hyderabad/India in Pharma External Supply Organization
  • Accompany of NOSSCEE (Novartis Operational Standards for Supply Chain Excellence), Project to establish Global Supply Chain Excellence and KPI Reporting to target a MRP2 Class-A Certification, audited by Oliver Wright Company
  • Direct reports to Head of Supply Chain and Steering Committee: project charter, project plan, project report, status reports,  risk plan including targets, milestones, resources, cost, expenses
  • Business Process Analysis, Gap Analysis and Optimization 
  • Development of value-creation and harmonized processes within all involved functions: Quality, Supply Chain, Sourcing and Finance 
  • Stakeholder Management
  • Change Management, Change Communication 
  • Training Development, Training Coordination 

Achievements:  

  • Improve Business Process including KPI Reporting of Master Data Management and Operational Sourcing to handover to new Master Data Team in Hyderabad/India (Business Process Offshoring/ Outsourcing) 
  • Delivered Change and Communication Strategy including Stakeholder Management 
  • Delivered Workshops, Trainings and Onboarding Strategy for new Master Data Team in India and all effected users and stakeholders 

  • Improve Business Process including KPI Reporting of Master Data Management and Operational Sourcing to handover to new Master Data Team in Hyderabad/India (Business Process Offshoring/ Outsourcing) 
  • Delivered Change and Communication Strategy including Stakeholder Management 
  • Delivered Workshops, Trainings and Onboarding Strategy for new Master Data Team in India and all effected users and stakeholders 
Novartis AG
Basel, Switzerland
7 Monate
2013-10 - 2014-04

Change Control Project with Oracle Agile integration, Global Technical Operations, Supply Chain

Project Quality Manager Computer System Validation, Document Man
Project Quality Manager Computer System Validation, Document Man
  • Implementation of an integrated system based on Oracle Agile PLM to change control and support product information management of regulatory relevant information for Pharma 
  • Preparation of key Computerized System Validation documents, such as Validation Plan and Validation Report, conducting Quality Risk Assessment
  • Coordination of the preparation of documents by adequate stakeholders 
  • Management of the review, approval and implementation process of project deliverables 
  • Definition of the Tollgate Report, tracking of Tollgate deliverables 

Achievements:  

  • Delivered Validation Strategy 
  • Delivered compliant system, no incidents 
  • Improved Project Documentation Management by implementing new concept for document archiving and approval process including Training for all writers and users 
Novartis AG
Basel, Switzerland
6 Monate
2013-05 - 2013-10

SAP Data Migration Project, Supply Chain Management

IT Business Analyst, SAP Data Migration Manager
IT Business Analyst, SAP Data Migration Manager
  • Integration of API Drug Substance and SRM Strategic Raw Material business in one single SAP plant for Multimarket business and Switzerland in Pharma Supply Chain 
  • Development of the data migration methodology & implementation plan 
  • Development of best practice, processes and standards for effectively carrying out data migration activities 
  • Analysis, cleansing, harmonization and migration of data 
  • Coordination of testing activities 
  • Change Management, Change Communication 
  • Training Development, Training Coordination 

Achievements:  

  • Delivered Migration and Cutover Strategy 
  • Assessed and delivered clean and proper Data for data migration activities 
Novartis AG
Basel, Switzerland
5 Monate
2012-12 - 2013-04

Business Transformation Project with SAP SCM integration, Supply Chain Management

Project Manager Change and Communication Management, Business Pr
Project Manager Change and Communication Management, Business Pr
  • Establishment of Master Data Organization in External Supply Chain Management 
  • Establishment of Supply Data Manager job role 
  • Integration of MDM Team to ESO Organization 
  • Business and IT Process Analysis and Optimization 
  • Improvement of Standard Organization Procedures including process flows 
  • Training Development, Training Coordination  
  • Change Management, Change Communication 

Achievements:  

  • Drive the organizational Change in Master Data Organization and make sure the functional solution fits to the global and local structures 
  • Delivered Change and Communication Strategy including Stakeholder Management 
  • Delivered Workshops and Trainings for users and stakeholders 
Novartis AG
Basel, Switzerland
3 Monate
2012-09 - 2012-11

SAP ? New Plant Implementation Project, Supply Chain Management

Project Manager Supply Master Data Management, Business Process
Project Manager Supply Master Data Management, Business Process
  • Implementation of a new SAP plant to concentrate all business operations for multimarket and European external supply activities in Pharma External Supply Organization 
  • Leading the Workstream for Master Data Management
  • Direct reports to Head of Supply Chain and Steering Committee: project charter, project plan, project report, status reports, risk plan including targets, milestones, resources, cost, expenses
  • Business Process Analysis and Optimization 
  • Development of value-creation and harmonized processes within all involved functions: Quality, Supply Chain, Sourcing and Finance 
  • Change Management, Change Communication 
  • Training Management, Training Coordination 

Achievements:  

  • Developed of Master Data Maintenance Strategy for Material, Vendor and Quality Master Data 
  • Delivered Concept for Master Data Governance 
Novartis AG
Basel, Switzerland
5 Jahre 1 Monat
2007-08 - 2012-08

Various Projects & Clients

Corporate Communication Manager, Public Relations Officer
Corporate Communication Manager, Public Relations Officer
  • Consulting for Strategy, Conception, Campaigning, Branding, Public Relations, Online & Social Media Relations, Digital Marketing, Corporate and Web Design 
  • Social Media Management, Content Management, Journalism, Editorials 
  • Event Management, Incentives 
  • Art & Culture Management, Bookings and Promotion 

Achievements:  

  • Developed Communication and Marketing strategies, that foster innovation in the digital space by adding cross-domain, cross-functional expertise on technology and business trends 
  • Reference Project: Developing and implement “VERSA” as digital avatar for VERSATEL to enforce Customer Relationship and Online Reputation Management on twitter, Facebook and diverse online forums (First Online Avatar in Germany) 
Agency for Corporate Communication and Strategy, Corporate Branding, Public and Social Media Relations, Digital Marketing and Design
Cologne, Germany
6 Monate
2012-02 - 2012-07

Various Projects

PMO Lead
PMO Lead
  • PMO/Project Management Officer to Program Manager Product Design & Innovations, Telekom Innovation Labs, Virtualized Infrastructure & Global Cloud IT, User Experience Design 
  • Project Management for Design Transformation and Global Talent Management, Change Management, Change Communication, Concepts & Text, Design Thinking, Agile/Scrum 

Achievements:  

  • Improve Talent Management Strategy to hire worldwide the most talented Designers for Deutsche Telekom Product Design 
Deutsche Telekom AG
Bonn, Germany
1 Jahr 1 Monat
2010-05 - 2011-05

Various TV Projects

Chief Editor/ TV-Journalism & TV-Production
Chief Editor/ TV-Journalism & TV-Production
  • TV Editorial, TV Production, Television reports, features, magazines, RTL Punkt 12, RTL exklusiv, VOX prominent  

Achievements:  

  • Developed TV-Production concept and editorial for TV-Features with ViPs like Topmodel Franziska Knuppe, Fashion Designer Talbot & Runhof and Guido Maria Kretschmar 
RTL Television
Cologne, Germany
7 Monate
2007-01 - 2007-07

Various Projects

Project Manager ? Online and Digital Marketing
Project Manager ? Online and Digital Marketing
  • Online Editorials, Internet/Intranet Content Management (TYPO 3, JOOMLA), CRM, Social Media, Festivals and Incentives, Conception, Campaigning, Branding 

Achievements 

  • Developed Sponsoring and Communication Concept for Love Parade Dortmund and other international Events and Festivals 
  • Developed new Micro-Website for Customer Services in TYPO 3 
Virtual Nights Media Ltd
Essen, Germany
7 Monate
2006-06 - 2006-12

Various Projects

  • Project Management, Event Management, Incentives, Sponsoring, Product Placement in TV and Cinema movie productions, Online Editorials, Internet/Intranet Content Management, CRM, Social Media, Festivals and Incentives, Conception, Campaigning, Branding 

Achievements:  

  • Increase the sells for Sponsoring and Customer Events over a 35 % during my procedure 
  • Delivered Marketing Strategy for Charity Golf Event of Deutsche Post and Kamps 
Movie Art Marketing
Dortmund, Germany

Aus- und Weiterbildung

Aus- und Weiterbildung

5 Jahre 1 Monat
2018-12 - 2023-12

CLINICAL AND HEALTH PSYCHOLOGY

B.Sc. CLINICAL AND HEALTH PSYCHOLOGY, SRH Riedlingen
B.Sc. CLINICAL AND HEALTH PSYCHOLOGY
SRH Riedlingen


3 Jahre 2 Monate
2020-05 - 2023-06

Advanced Studies in Coaching

DIPLOMA of Advanced Studies in Coaching, ZHAW, Insitute of Applied Psychology, Zurich
DIPLOMA of Advanced Studies in Coaching
ZHAW, Insitute of Applied Psychology, Zurich


2 Jahre 7 Monate
2020-05 - 2022-11

CAS in Solution-focused Therapy and Counselling

ZHAW, Insitute of Applied Psychology, Zurich
ZHAW, Insitute of Applied Psychology, Zurich


2 Jahre 5 Monate
2019-03 - 2021-07

Infromation Technology in Healthcare

Master of Science, Donau Universität Krems
Master of Science
Donau Universität Krems
9 Monate
2019-06 - 2020-02

ISO 27001 Certificate 

ISO 27001 COMPLIANCE OFFICER & LEAD AUDITOR, Certificate , TÜV Rheinland
ISO 27001 COMPLIANCE OFFICER & LEAD AUDITOR, Certificate 
TÜV Rheinland
1 Monat
2018-09 - 2018-09

HUMAN FACTORS/ USABILITY ENGINEERING (IEC 62366, IEC 60601, ISO 14971, FDA), Certificate

Johner Institute, Konstanz
Johner Institute, Konstanz
1 Monat
2018-06 - 2018-06

MEDICAL DEVICE SOFTWARE DEVELOPMENT, VALIDATION AND VERIFICATION, Certificate

Johner Institute, Konstanz
Johner Institute, Konstanz
1 Monat
2018-05 - 2018-05

IT AND CYBER SECURITY & DATA PROTECTION FOR MEDICAL DEVICES, Certificate 

Johner Institute, Konstanz 
Johner Institute, Konstanz 


1 Monat
2018-05 - 2018-05

REGULATORY AFFAIRS FOR MEDICAL DEVICES, Certificate 

Johner Institute, Konstanz 
Johner Institute, Konstanz 


7 Monate
2017-10 - 2018-04

REQUIREMENTS ENGINEERING FÜR BUSINESS ANALYSTEN, Certificate

SGO Zürich 
SGO Zürich 
7 Monate
2017-10 - 2018-04

BPMN 2.0 BUSINESS PROCESS MODEL AND NOTATION, Certificate

SGO Zürich
SGO Zürich


7 Monate
2017-10 - 2018-04

GROUP DYNAMICS, Certificate

SGO Zürich
SGO Zürich


1 Monat
2015-06 - 2015-06

eREGULATORY AND INTELLIGENCE/ ISO IDMP

Drug Information Association DIA, Philadelphia/ US 
Drug Information Association DIA, Philadelphia/ US 
1 Monat
2014-06 - 2014-06

OPERATIONAL SOURCING MANAGER SAP SCM/ Contract & Price Management in pharmaceutical industries

OPERATIONAL SOURCING MANAGER, Novartis 
OPERATIONAL SOURCING MANAGER
Novartis 

1 Monat
2014-02 - 2014-02

SYSTEMIC BUSINESS COACHING

St. Galler Management Model, University of Applied Sciences: Technology, Business and Design, Wismar
St. Galler Management Model, University of Applied Sciences: Technology, Business and Design, Wismar
1 Monat
2013-11 - 2013-11

IT-Project Management & Computer System Validation in pharmaceutical industries

CERT. PROJECT QUALITY MANAGER, Novartis
CERT. PROJECT QUALITY MANAGER
Novartis
1 Monat
2013-02 - 2013-02

Supply Chain Data Management in pharmaceutical industries

SUPPLY DATA MANAGER SAP SCM, Novartis
SUPPLY DATA MANAGER SAP SCM
Novartis
1 Monat
2013-02 - 2013-02

CHANGE MANAGEMENT & ORGANIZATIONAL DEVELOPMENT

CERT. SYSTEMIC CONSULTANT/ AGENT FOR CHANGE MANAGEMENT & ORGANIZATIONAL DEVELOPMENT, Alwart institute, Hamburg
CERT. SYSTEMIC CONSULTANT/ AGENT FOR CHANGE MANAGEMENT & ORGANIZATIONAL DEVELOPMENT
Alwart institute, Hamburg
1 Monat
2008-09 - 2008-09

PUBLIC RELATIONS & PRESS OFFICE MANAGEMENT

JOURNALIST FOR PUBLIC RELATIONS & PRESS OFFICE MANAGEMENT, German Institute for Publicity & Journalism, Hagen
JOURNALIST FOR PUBLIC RELATIONS & PRESS OFFICE MANAGEMENT
German Institute for Publicity & Journalism, Hagen
1 Monat
2002-06 - 2002-06

BUSINESS ADMINISTRATION Apprenticeship

MANAGEMENT ASSISTANT BUSINESS ADMINISTRATION Apprenticeship, Volkswagen/Audi, Dortmund
MANAGEMENT ASSISTANT BUSINESS ADMINISTRATION Apprenticeship
Volkswagen/Audi, Dortmund
1 Monat
1999-06 - 1999-06

BUSINESS ADMINISTRATION

DIPLOMA IN BUSINESS ADMINISTRATION, Commercial High School, Unna
DIPLOMA IN BUSINESS ADMINISTRATION
Commercial High School, Unna


Kompetenzen

Kompetenzen

Top-Skills

Digital Health Quality Management Computer System Validation ISO 27001 DIN EN ISO 13485 IEC 62304 Auditor Requirement Engineer Business Analyst Business Process Modeling 21 CFR Part 820 Agile Softwareentwicklung Software as a Medical Device SaMD ISO 14971 Software Lifecycle IT Security nach BSI GAMP Biotechnology GMP 21 CFR cloud transformation SAP HANA IaaS

Aufgabenbereiche

Audit Management
Business Analysis
Digital Health Solutions
GAMP 5 Computer Software Validieren
IEC 62304
ISO13485
Qualitätsmanagement (Einführung...)
Requirements Engineering
Software as a Medical Device
Usability Engineering

Produkte / Standards / Erfahrungen / Methoden

Application Lifecycle Management
ARIS Plattform
Atlassian Confluence
Atlassian JIRA Agile
Bio-Technologie
Business Process Analysis
Change Management
Complaint Management
Documentum D2
Good Laboratory Practice
ISO 27001
Knowledge Management
Labware
RequirementEngineering
SAP ERP
SAP SolMan
Werum IT Solutions

Industry Standards and Methods:

ISO (ISO-9000 and 14971),  GAMP5


Regulations:

  • ICH, FDA, WHO, EMA
  • Annex/Part 11, predicate GLP, GCP, GMP rules
  • ISO IDMP, eCTD


Office Applications:

  • MS Office (Excel, Word, PowerPoint, SharePoint, Visio, Project), Outlook, SharePoint
  • Mac iWork, Mac Mail
  • IBM Lotus Notes


Skills:

  • Master of Science in Information Technology in Healthcare
  • IT Security Officer & Auditor for ISO 27001 (TÜV), Cyber Security ISACA/ BSI
  • Business Analyst & Requirements Engineer (IREB, UX, Human Centered Design)
  • IT Quality & Regulatory Compliance Auditor (GxP, EMA, FDA)
  • Quality Management System Expert (Pharmaceutical, Biotechnology, Medical Devices, Healthcare)
  • Computer System Validation & Software Verification Specialist (Digital Health Solutions, GAMP 5, FDA CSA)
  • SaFe Scrum Master, Coach & Organizational Change Manager (ZHAW IAP)


Profile:

  • Her heart has been beating for lean and effective quality management in the medical technology, biotechnology and pharmaceutical industry for over 15 years. She is passionate about new technologies for digital transformation in healthcare, from Digital Health Platforms to Health Apps/ Software as a Medical Device to GxP compliant computer systems for business process automation
  • She accompanies medical technology start-ups and SMEs in the development and introduction of digital product innovations. For this purpose, she has designed her own regulatory roadmap from her years of experience in the pharmaceutical industry, biotechnology and medical technology, which promises a product launch within 12 months. This "fast track" begins with the generation of ideas, through the establishment of a quality management system and technical documentation, to the market launch. It also includes building a digital integrated ecosystem with cutting-edge technologies
  • She also has more than 18 years of experience in global corporate roles and multicultural and multidisciplinary IT and business transformation projects and programs with extensive expertise and professional experience in regulated environments. In doing so, she leads nearshore and offshore teams in multiple locations
  • She is known as an Excellent Writer, Presenter and Facilitator for global projects with large audiences, customer focused, always motivated to exceed expectations and go the extra mile


Provided Consulting Services are:

  • Digital Transformation in Healthcare & Life Science, Digitalization of business processes and modern IT architecture
  • Regulatory Compliance and Audits within Pharmaceuticals and Medical Device industry (GxP, EMA, FDA, PIC/S, ISO, MDR, ICH)
  • Quality Management and Assurance for Software Development of Digital Health Solutions, Medical Device Software, Software as a Medical Device and Computerized Systems (ISO 13485, FDA 820)
  • Computer System & Software Validation and Verification (IEC 62304/ 82304, GAMP 5 2nd Edition/CSV, FDA CSA)
  • Electronic Records & Signatures/ ERES (Annex 11, Part 11)
  • Data Integrity, Data Governance & Migration
  • Quality & Product Risk Management (FMEA, ISO 14971)
  • Information & Cyber Security Management ISO 27001 TÜV SÜD certified Compliance Officer, ISACA/BSI certified Cyber Security Practioner
  • Business Analysis and Requirements Engineering (BABOK, IREB)
  • Usability & User Experience, Human-Centered Design (UXQB, IEC 62366)
  • Business Process Modeling & Transformation, BPMN 2.0
  • Digital and Mobile Solutions Development, Cloud Solutions, Data Repository, Digital Health Platforms (IoT), Digital Therapeutics DTx, DIGA, Digital Health Apps, SaMD Software as a Medical Device
  • Systemic Organizational Development, Change and Communication Management
  • Business Coaching (St. Galler Management Model, Systemic Coaching, solution-resource oriented Counselling, Hypnotherapy, Introvision etc.)
  • Agile & Lean Methods, SAFe Scrum Master
  • Project Management & Facilitator


Primary Expertise:

  • Quality Management and Assurance for Software Development of Medical Device Software and Computerized Systems
  • Regulatory Compliance and Audits within Pharmaceuticals and Medical Device industry (EMA, FDA, PIC/S, ISO, MDD/MDR, ISO)
  • Quality Risk Management (FMEA, ISO 14971)
  • Software Validation and Verification (IEC 623304/82304, GAMP 5/CSV)
  • Business Analysis/ Requirements and Usability Engineering (BABOK, IREB, IEC 62366)
  • Information Security Management ISO 27001


Related Experience:

  • Digital Health (SaMD)
  • Cloud Solutions/ Mobile Applications
  • Information & Data Security, Data Integrity, Data Privacy
  • Project Management/ Agile Methodology/ Scrum
  • Business Process Modeling & Transformation, BPMN 2.0
  • Change and Communication Management/ Training and Coaching, Workshops
  • Master Data Governance, Data and Migration Management
  • MRP II Class A/ Business Excellence/ Oliver Wight
  • ITIL V3 Foundation
  • Good Documentation and Technical Writing Skills


Client List:

  • Air Liquide, Düsseldorf/DE
  • Abbot, Hannover/DE
  • Möller Medical Fulda/DE
  • BioNTech
  • Beiersdorf AG, Hamburg/DE
  • EKF Diagnostics Barleben/DE Telefónica, Düsseldorf/DE
  • Karl Storz, Tuttlingen/DE
  • LONZA, Basel/CH
  • Sanofi Aventis, Frankfurt/DE, US
  • Camlog/Altatec, Basel/CH, Wimsheim/DE
  • Sutter Medizintechnik, Freiburg/DE
  • Fresenius Kabi SwissBioSim, Eysin/CH
  • Fresenius Kabi Digital Lab, Berlin/DE
  • Fresenius Kabi, Germany, Switzerland, Italy, Spain, South America
  • Novartis Pharma, Basel/CH, US, Dublin/IR, Stein/CH
  • Deutsche Telekom, Bonn/DE
  • Evonik (Degussa) AG, Düsseldorf/DE
  • RWE AG, Essen/DE


Business Software, Hardware, Firmware:

  • Philips HealthSuite digital platform
  • BrightInsight Digital Health Platform - Internet of Things platform for BioPharma and MedTech
  • Laboratory Systems: Perkin Elmer, eLN and Spotfire, Labware LIMS, BIOVIA, D-Wise CAP SAS, Thermo Fisher Chromeleon, Rotronic Monitoring System RMS
  • ITSM IT Service Management ? BMC Remedy ITSM Suite, SAP NetWeaver, SAP Solution Manager, Service Now
  • Service Now Discovery for IT Infrastructure
  • JIRA Service Desk for IT Demand Management and Software Development
  • CONFLUENCE Content Collaboration-Software
  • ERP ? SAP SCM, MM-PUR, WM, PP, PM Plant Maintenance, MMP Procurement (Material Management) incl. all objects: BOM, PR, SL, Contract and Purchase Order, Order Fulfillment (Sales Order Management), Vendor Master Data (including SIM Tool authorization), Quality Master Data, R/3 HR, ESS
  • SAP Hana Cloud (Application for Digital Home & Healthcare)
  • MES Manufacturing Execution Systems (ATLAS, PAS-X, PMX, Rockwell), MMC Material Movement Controller
  • ALM & Test Management - HP Quality Center/ PROTON Test Software, SAP Solution Manager (Implementation, Test Workbench)
  • BPM Business Process Modelling ? ARIS
  • CMS Content Management ? Vignette, Microsoft Office SharePoint Server (ECM), MODx, TYPO3, Wordpress, HTML
  • Document Management - Documentum D2 and Life Science Suite, Veeva, Microsoft SharePoint
  • CRM Customer Relationship Management ? Mamis (Deloitte), vtiger, Daylite, salesforce
  • Project Management - Microsoft Project, Biquanda (ehem. OpenTime), Open Workbench, Sciforma, Project Scheduler, GRANEDA Dynamic, GANTT project, MindManager

Programmiersprachen

Business Process Modeling Notation

Hardware


    Design / Entwicklung / Konstruktion

    agiles Projektmanagement
    Conception
    Data Quality
    Data-Migration
    FMEA
    Requirement Analyse

    Managementerfahrung in Unternehmen

    Auditor
    Computer System Validation
    GxP-Compliance
    Qualitätsicherung
    Software Lifecycle
    Software Quality Assurance

    Interim Management and Leadership:

    • Quality and Compliance Manager
    • Change and Transformation Manager
    • IT Project Manager, Business Analyst/ Engineer

    Branchen

    Branchen

    • Regulated Industry
    • Pharmaceutical
    • Medical Device
    • BioTech
    • Med Tech

    Einsatzorte

    Einsatzorte

    Frankfurt (+50km) Berlin (+20km) Hamburg-Mitte (+20km) Basel (+10km) Zürich (+10km)
    Deutschland, Schweiz, Österreich
    auch weltweite Reisen und Einsatz möglich
    möglich

    Projekte

    Projekte

    1 Jahr 1 Monat
    2023-02 - heute

    Service Delivery and direct report

    IT Business Partner for IT Transformation
    IT Business Partner for IT Transformation

    • Large holistic transformation and change program in which different system landscapes (SAP, ERP, Salesforce from different countries) are to be unified (considering local regulations)
    • The project is in the area of IPG (Integrated Package Gas) and Supply Chain
    • Create target/actual analysis of the above-mentioned system landscapes (participation in workshops, documentation, develop strategies, sell ideas)
    • Independent negotiations with department heads and other management levels for the possible implementation of topics in the Integrated Package Gas area
    • Independent definition of IT-technical components and requirements
    • Advice on compliance with the implementation and deadlines for topics arising from the target/actual analysis
    • Advising staff on the relevant work tasks and processes and change management

    gladly on request
    Düsseldorf and worldwide
    1 Jahr 5 Monate
    2022-10 - heute

    Implementation of a digital health platform for product innovation

    Strategy Consultant & Project Lead ? Digital Transformation
    Strategy Consultant & Project Lead ? Digital Transformation

    Service Delivery and direct report to Head of Innovation and Development

    • Creation of URS document for DHP including Regulatory & quality requirements/controls, SLCM & validation requirements, Data protection & security requirements
    • Creation of Architecture Handbook for DHP (build on Cloud Computing/Xaas)
    • Manage and coordinate DHP Design Workshop
    • Lead and coordinate Supplier Selection process for DHP/ Cloud Services, pre-selection of suitable suppliers based on created supplier questionnaire,
    • Audit Supplier regarding ISO 13485 and IEC 62304 as well as IT & Cyber Security (Cloud Security Alliance) and System Lifecycle processes (BSI Compendium, ISO 27001)
    • Run Supplier Demos and perform Gap Assessment with recommendations for contract negotiation
    Möller Medical
    Fulda/DE
    2 Jahre 2 Monate
    2022-01 - heute

    Service Delivery and direct report

    CSV/ Quality & Compliance Strategy Consultant for Digital Manufacturing (MES)
    CSV/ Quality & Compliance Strategy Consultant for Digital Manufacturing (MES)

    Service Delivery and direct report to Head of IT Compliance & GMP Quality

    • Global Rollout of MES to all local production sites (Pilot Sites: Poland, Brazil, Mexico, Thailand)
    • Establish Global and local Validation Strategy for Core MES (Traksys & Promas plus Interfaces to Movement Controller, LIMS, Siemens S7 etc.)
    • Creation of Validation Master Plan incl. CSV Templates for Validation Plan & Report, Supplier Audit, Risk Management (based on new GAMP 5 2nd edition, FDA CSA and Agile methods)
    • Accompany and perform Validation activities and documentation, run CSV MVP1 in Poland and Update of Validation Strategy and Templates
    • Conduct IT Supplier Audits
    • Manage Retro & Lessons Learned Workshop with all regulated production sites
    Beiersdorf AG
    Hamburg and worldwide
    3 Jahre 2 Monate
    2021-01 - heute

    Building a Lean & Agile Quality Management System

    Quality Manager & Auditor, Prozess Manager ISO 9001 Audits Prozessmodelierung ...
    Quality Manager & Auditor, Prozess Manager
    ISO 9001 Audits Prozessmodelierung Digital Asset Management
    Basel
    1 Monat
    2023-02 - 2023-02

    Digital Health Innovations

    CEO & Founder, Quality & Compliance Manager, Auditor
    CEO & Founder, Quality & Compliance Manager, Auditor

    • Quality & Compliance Strategy Consultant for Digital Health Innovations
      • Combination products (BioTech/MedTech)
      • Software as a Medical Device, Digital Health Apps, Digital Therapeutics, DIGA
      • Exoskeleton, Software Apps and Digital Health Platforms
      • Health Information Platforms for RWD, Genetic/DNA data, R&D
    • Service Delivery and direct report to CEOs, CIOs, Global Quality & Regulatory Heads
      • Audit and Assessment of regulatory landscape for Product Classification and Development, define scope technical documentation to achieve conformity
      • Encourage and develop V&V strategy for Product Development 62304/82304 and achieve CE Mark or market access (EU/US)
      • Concept & Design of QMS (Biotech, MedTech) and achieve certification (EMA, FDA, Notified Body)
      • Build Cloud & Data Repository Strategy for Digital Health Platform as part of Medical Device or SaMD
      • Build IT Operating Model (ITIL, IT4IT, SAFe DevOPs, Scrum) including Computer System Validation GAMP 5, Annex 11, Part 11, IT & Cyber Security ISO 27001, BSI, ISACA,
      • Implement Supplier Management & Governance Model
      • Design, coordinate and moderate Workshops ? onsite and remote, using interactive digital presentations and moderation tools (Teams, Zoom, Webex, MIRO, MURAL, Mentimeter, Asana, JIRA, Confluence etc.)

    gladly on request
    Basel/CH
    11 Monate
    2022-02 - 2022-12

    Digitalization new iNeST Manufacturing Facility

    Senior Project Manager & Specialist Digitalization new iNeST Manufacturing Facility (Next Generation Immunotherapy)
    Senior Project Manager & Specialist Digitalization new iNeST Manufacturing Facility (Next Generation Immunotherapy)

    Service Delivery and direct report to Head of Global Digitalization Projects & Site Head

    • Develop, establish and drive MES Core Strategy and rollout concept for manufacturing sites (Release & Change Management, Requirement Management within Azure Devops, Validation Strategy)
    • Lead Fit/Gap Workshops and support BNT Experts in defining/ prioritizing potential software gaps
    • Manage delivery of 5 MBR blueprints according to process specification for review & test for Pilot Facility. (MBRs, GMBRs, ESP, Master data)
    • Consult MBR specification creation, Consult Label design and configuration in PAS-X for ca. 10 labels according to specification.
    • Establish continuous improvement of MBR Design following process & interface clarification.
    • Consult completion of qualified installation of system environment
    • Build and enroll Project Governance Model
    • Lead Project Management (Project Plan, Risks, Budget, Resources)
    • Facilitate and engage stakeholders from PM, IT, QA, CSV and Business
    • Design, coordinate and moderate Workshops for MES System Implementation (Fit-Gap-Analysis, Blueprint Design, Verification Strategy etc.)

    BioNTech
    Mainz/DE
    11 Monate
    2022-02 - 2022-12

    Cloud Transformation Program

    TECH Senior Cyber Risk Consultant for Cloud Transformation Program
    TECH Senior Cyber Risk Consultant for Cloud Transformation Program

    Service Delivery and direct report to Head of Global Digitalization Projects

    • Plan, coordinate and control the software development within RAITT to check that all software packages have the needed compliance requirements implemented:
      • Definition of low-level security design
      • Implementing of the new Security, Compliance, Risk and Data Protection controls
      • Independent coordination of technical units within the scope of analysis and implementation of the above-mentioned new functionalities
      • Create a low-level specification document for new controls to be developed within RAITT
      • Project management for software development monitoring that the controls mentioned above are implemented correctly
    Telefónica
    Germany
    1 Jahr 8 Monate
    2021-05 - 2022-12

    Cloud Transformation Program

    Quality & Compliance Strategy Consultant 
    Quality & Compliance Strategy Consultant 

    • Cloud Transformation Program with focus on CSV & IT Security Strategy (Azure Cloud, XaaS, SAP 4HANA)
    • Service Delivery and direct report to Head of IT Compliance & GMP Quality
      • Improvement and update of BSS/BDF Validation Strategy Incl. CSV Policy, Templates for Validation Plan & Report, Supplier Management, Risk Management (based on new GAMP 5 2nd edition and FDA CSA)
      • Encourage and develop global Strategy for Qualification and Validation of Cloud Solutions (Iaas, Paas, SaaS, Kubernetes) used for medicinal and GxP-relevant data
      • Transition from on premise to Cloud Strategy (Azure, SAP 4HANA)
      • Scope: Computer System Validation GAMP 5, Annex 11, Part 11, IT & Cyber Security ISO 27001, BSI, ISACA
      • Conception Validation Strategy Incl. Policy, Templates for Validation Plan & Report, Supplier Management, Risk Management

    Beiersdorf AG
    Hamburg
    1 Jahr
    2021-12 - 2022-11

    Consulting services for the preparation

    Strategy Consultant for Digital Health App & SaMD, Service Delivery and direct report to Global Director, Devices and Instrumentation
    Strategy Consultant for Digital Health App & SaMD, Service Delivery and direct report to Global Director, Devices and Instrumentation

    Consulting services for the preparation of technical documentation for EKF Link

    • New Product Release of POC data management system EKF Link
    • IVDR Update
    • Concept SLCM with Supplier
    • Update QMS 13485 with IEC 62304/82304
    EKF Diagnostics, Barleben/DE
    2 Jahre 3 Monate
    2019-10 - 2021-12

    Agile Computer System Validation

    Quality and Compliance/ CSV Strategy Consultant
    Quality and Compliance/ CSV Strategy Consultant

    Service Delivery and direct report to Quality Assurance and Regulatory Affairs Management

    • Giving Strategy and Advice to establish a Software Development Framework for Agile Software Development under CSV based on Scrum Methodology within JIRA and Confluence
    • Conception and Realization of Validation Strategy for the Development and Implementation of local Implementation of IT Systems for a Unified Lab Management software (BIOVIA) within the Research & Development Center of FKSB
    Fresenius Kabi SwissBioSimiliar
    Eysin/CH
    1 Jahr 9 Monate
    2020-02 - 2021-10

    Digital Health Systems, Software as a Medical Device

    Quality & Compliance Strategy Consultant 
    Quality & Compliance Strategy Consultant 

    • Digital Health Systems, Software as a Medical Device (SaMD) and Digital Health Platform
    • Service Delivery and direct report to Project Management, Quality Assurance and Regulatory Affairs
      • Encourage and develop global Strategy for Qualification and Validation of Digital Health Platforms IoT) used for medicinal and GxP-relevant data (Iaas, PaaS, Saas, Kubernetes), ISO 13485 & ISO 27001
      • CSV/ Validation Responsible during Supplier Assessment for PaaS
      • Validation Management as Project Quality Manager for Digital Health Platforms
    Novartis Pharma, TRD and NBS
    Basel/CH, Dublin/IR and worldwide
    6 Monate
    2021-03 - 2021-08

    Digital Health Systems, Software as a Medical Device

    Quality & Compliance Strategy Consultant
    Quality & Compliance Strategy Consultant

    • Digital Health Systems, Software as a Medical Device (SaMD) and Digital Health Platform
    • Service Delivery and direct report to Project Management, Quality Assurance and Regulatory Affair
      • Encourage and develop global Strategy for Qualification and Validation of Digital Health Platforms used for medicinal and GxP-relevant data (PaaS, Kubernetes)
      • CSV/ Validation Responsible during Supplier Assessment for PaaS
      • Validation Management as Project Quality Manager for Digital Health Platforms
    Novartis Pharma, TRD and NBS
    Basel/CH, Dublin/IR and worldwide
    5 Monate
    2021-03 - 2021-07

    Cloud CSV & IT Security Strategy (Azure, SAP, RIMS)

    Quality & Compliance Strategy Consultant 
    Quality & Compliance Strategy Consultant 

    Service Delivery and direct report to Head of IT

    • Encourage and develop global Strategy for Qualification and Validation of Cloud Solutions (Iaas, Paas, SaaS, Kubernetes) used for medicinal and GxP-relevant data
    • Scope: Computer System Validation GAMP 5, Annex 11, Part 11, IT & Cyber Security ISO 27001, BSI, ISACA
    • Conception Validation Strategy incl. Policy, Templates for Validation Plan & Report, Supplier Management, Risk Management
    Nordmark Pharma
    Hamburg
    11 Monate
    2019-07 - 2020-05

    Development Software as a Medical Device (SaMD)

    Project Manager
    Project Manager

    Service Delivery and direct report to Quality Head and Program Lead

    • Project Management within Global Program for Software Development and Launch of Software as a Medical Device (SaMD) used for Diabetes Care
    • Giving Strategy and Advice to establish and improve Corporate Framework within existing QMS 13485 for Software Development, Verification and Validation of Health Apps, fulfilling new MDR requirements
    • Quality Management support to extend QMS 13485 with relevant procedures and working instructions for Regulatory Compliance with new Medical Device Regulation (MDR) regarding SaMD, transfer to class 2a and 2b
    • Business Process Design within SharePoint, Confluence, JIRA and other Tools for usage as a regulated and validated QMs, Lifecyle and Document Management System (Workflows, Templates, Technical File, Electronic Records and Signatures)
    Sanofi Aventis
    Frankfurt/DE and worldwide
    4 Monate
    2019-11 - 2020-02

    Transfer Software as a Medical Device (SaMD) to Class II (MDR Update)

    Quality & Risk Manager
    Quality & Risk Manager

    Service Delivery and direct report to Quality Assurance and Product Owner

    • Transfer of SaMD for Parenteral Nutrition Management within hospitals in Europe from class I to class IIa (new MDR)
    • Quality Management support to extend QMS 13485 with relevant procedures and working instructions for Regulatory Compliance with new Medical Device Regulation (MDR) regarding SaMD
    • Transfer of SaMD from class I to class IIa (new MDR)
    • Review and Update of Technical Documentation, giving advice to Software Development Team
    • Conduct Risk Assessment for SaMD
    Fresenius Kabi Espana
    Barcelona/ES
    6 Monate
    2019-07 - 2019-12

    Development Software as a Medical Device (SaMD)

    Quality & Risk Manager
    Quality & Risk Manager

    Service Delivery and direct report to Quality Assurance and Product Owner

    • Risk Manager for SaMD, conducting all levels of risk management according to ISO 14971 (Risk Policy, PHA, FMEA)
    • As Quality Manager: Quality Review and Compliance Check of Technical Documentation, giving advice to Software Development Team (IEC 62304, ISO 13485)

    Vifor Pharma
    Zürich/CH
    2 Jahre 2 Monate
    2017-11 - 2019-12

    Service Delivery

    Global IT Quality and Compliance Strategy Consultant, Program Quality Lead, Senior Business Analyst and Requirements Engineer
    Global IT Quality and Compliance Strategy Consultant, Program Quality Lead, Senior Business Analyst and Requirements Engineer

    Service Delivery and direct report to Head of Global Quality and Global IT Management

    • Conception and Realization of a Global Competence Center for Computer System Validation to ensure worldwide Quality Assurance and Compliance of gxp-relevant IT systems and projects, including implementation of CSV Knowledge Management and Quality Assurance Unit worldwide
    • Conception and Process Design of One Global IT Architecture Landscape for a validated Global Application Lifecycle Management, integrating all Global IT Systems through harmonized Business Process & Business Requirement Management, System Specification and Test Case Design (using ARIS BPM Tool), including Change Control and Change Impact Analysis
    • CSV/ Software Validation of ARIS BPM Tool to manage all business process/ system changes and validation documentation (URS, FS, RA, Test Scripts) within ARIS (validated Approval workflow without print outs)
    • CSV/ Software Validation of new implementation of Service Now Discovery/ IT Infrastructure
    • CSV/ Software Validation and Quality Assurance of global Archive System in compliance with Data Integrity and EU-DSGVO, creation of business requirements and SOPs/ WIs regarding Data Integrity and ERES regulations
    • CSV/ Software Validation and Quality Assurance, Program Quality Lead of global Cloud Solution
    • CSV/ Software Validation and Quality Assurance, Program Quality Lead for Office 365 corporate Implementation and Global Rollout (Lotus Notes to Office 365), including Data Migration Projects for GxP-relevant IT System to SharePoint or Documentum D2
    Fresenius Kabi
    worldwide
    6 Monate
    2019-01 - 2019-06

    R&D Laboratory Relocation BioSimiliar

    Quality & Compliance Manager/ Auditor for CSV Computer System Validation Software Lifecycle Data Quality ...
    Quality & Compliance Manager/ Auditor for CSV
    • Quality Assurance for Computer System Validation of Laboratory Relocation and Integration of Global IT Systems for Document Management (eCTD, eTMF, CTM, eLN)
    • Auditing of Supplier of It Systems
    • Requirement Analysis and Engineering for URS
    Documentum D2 Good Laboratory Practice Labware
    Computer System Validation Software Lifecycle Data Quality Auditor Data-Migration Software Quality Assurance agiles Projektmanagement Requirement Analyse Conception Bio-Technologie
    Fresenius Kabi SwissBioSim
    Eysin
    1 Jahr 3 Monate
    2018-01 - 2019-03

    Medical Device Software/ System Development, Validation + Verification Framework for Digital Health Apps

    Quality Assurance CSV and Medical Device Software Validation Scrum ISO13485 IEC 62304 ...
    Quality Assurance CSV and Medical Device Software Validation

    Service Delivery and direct report to Managing Director Digital Lab for Software Development of Medical Device Software and Computerized Systems

    Fresenius Kabi Digital Labs GmbH, Berlin

    • Conception and Realization of Software Development Framework for Digital and Mobile Solutions based on Scrum Metholodgy combining regulated Life Cycle Documentation of Medical Device Software Validation and Verification and Computer System Validation
    • Validation Strategy and Management for Digital Health Medical Apps
    • Validation Concept and Management for Software Validation of JIRA Confluence for usage as validated Project and Documentation Software within Digital Lab
    • Quality Management support to implement Quality Management System ISO 134585 and ISO 9001 into Digital Labs (QMS Handbook, Procedures, Internal Audits)
    • Regulatory Compliance within Pharmaceuticals and Medical Device industry (EMA, FDA, PIC/S, ISO, MDD)
    • Quality Risk Management (FMEA)
    • Software Validation and Verification (IEC 62304/82304, GAMP 5), Usability Testing
    • Training and Coaching in regards to Computer System Validation and Regulatory Compliance
    • Stakeholder Management within Fresenius Quality Community
    Atlassian Confluence Atlassian JIRA Agile Usability Testing Computer System Validation Application Lifecycle Management FMEA
    Scrum ISO13485 IEC 62304 Software Quality Assurance Audit ISO 27001
    Fresenius Digital Labs GmbH
    Berlin
    6 Monate
    2018-01 - 2018-06

    Building a Global CSV Competence Center

    IT Quality and Compliance Strategy Consultant, Senior Business A Computer System Validation Business Process Analysis Business Process Modeling Notation ...
    IT Quality and Compliance Strategy Consultant, Senior Business A
    • Conception and Realization of a Global Competence Center for Computer System Validation to ensure worldwide Quality Assurance and Compliance of gxp-relevant IT systems and projects, including im-plementation of CSV Knowledge Management and Quality Assurance Unit worlwide
    • Conception and Process Design of One Global IT Architecture Landscape for a validated Global Application Lifecycle Management, integrating all Global IT Systems through harmonized Business Process & Business Requirement Management, System Specification and Test Case Design (using ARIS BPM Tool), including Change Control and Change Impact Analysis
    • CSV/ Validation of ARIS BPM Tool to manage all business process/ system changes and validation doc-umentation (URS, FS, RA, Test Scripts) within ARIS (validated Approval workflow without print outs)
    • Conception and Realization of CSV Framework and QMS for the new Digital Lab of Frensenius (Digital Healthcare and Mobile and Medical Devices), implementing Confluence as validated Project and Documentation Software
    • CSV/ Validation of new implementation of Service Now Discovery
    • CSV/ Validation of global Archive System in compliance with Data Integrity and EU-DSGVO, creation of business requirements and SOPs/ WIs in regrads to Data Integrity and ERES regulations
    ARIS Plattform Atlassian Confluence Documentum D2 SAP ERP SAP SolMan
    Computer System Validation Business Process Analysis Business Process Modeling Notation Software Quality Assurance GxP-Compliance Application Lifecycle Management RequirementEngineering Knowledge Management Change Management Qualitäts Management ISO 9001 GAMP
    worldwide
    2 Jahre
    2016-01 - 2017-12

    Strategy Consultant Computer System Validation

    Global Quality Management, Global Quality and System Compliance GxP-Compliance Audit Application Lifecycle Management ...
    Global Quality Management, Global Quality and System Compliance
    • Giving Strategy and Advice to establish a Corporate Framework for Project Governance of Computer System Validation (risk-based approach GAMP5)
    • Ensure the Corporate Framework and corresponding Global Operating Procedures are  fully integrated into Fresenius Kabi Global IT Strategy
    • Ensure that computer system validation strategy is effectively implemented for all GxP systems and that they remain compliant throughout their life-cycle
    • Support the development of compliance standards (e.g. Global Operating Procedures, templates, and training materials) as well as IT project related documents in line with Fresenius quality and regulatory requirements in the respective IT function.
    • Liaise effectively with Quality and IT personnel across Fresenius Kabi as well as other Divisional quality and business functions to ensure that standards and effective processes for governing GxP computerized systems are in place, maintained and opportunities for continuous improvement identified and implemented
    • Support the development and delivery of training relevant for Quality, IT and business functions in the area of computerized systems compliance

    Global IT Programs: eDMS, SAP, MES, TRACKWISE, Complaint Handling Tool

    Documentum D2 Werum IT Solutions
    GxP-Compliance Audit Application Lifecycle Management Qualitätsicherung Knowledge Management Complaint Management Computer System Validation Business Reporting
    Fresenius Kabi
    Bad Homburg, Germany
    3 Monate
    2015-10 - 2015-12

    IT Quality and Compliance Manager with focus on IT Transition, Information Governance and Risk Management

    • Ensuring that the transition projects and applications are managed in compliance with IGM requirements, e.g. Novartis project management methodology (“ICE”)
    • Validating all project and system life cycle documents in compliance with IGM/ICE and CSV to force the acceptance of transition, developing document management and archiving concept for all audit relevant documents
    • Verify that all project-related tests are conducted according to the project quality plan and in compliance with IGM requirements.
    • Perform quality reviews for audit readiness, identify and document all project observations, gaps and risk with associated mitigation strategies
    • Support the problem solving of project and quality risk and provide quality guidance on GxP regulatory requirements (including, but not limited to 21 CFR Parts 11, 820 and EU GMP Annex 11.)
    • Schedule sessions with Project and Operations Team to drive mitigation actions on gaps and risks
    • Ensure Acceptance Meetings, Knowledge Transfer and Asset identification for project transition
    Novartis AG
    Basel, Switzerland
    11 Monate
    2014-12 - 2015-10

    Senior IT Business Analyst with focus on Manufacturing and Logistics, IT Service Management

    Interim Management at Local IT, Manufacturing and Logistics
    Interim Management at Local IT, Manufacturing and Logistics
    • Managing Service Delivery Management: incident, service request and change management processes for IT applications of the integrated IT warehousing, material flow and distribution system environment in PharmOps Switzerland (MES, SAP WM (ERP), GISC Labeling and Material Movement Controller 
    • Support and demand management for the ‘SU Process and Logistics Services’ concerning application operations and projects (e.g. warehouse refurbishment, weighing & dispensing)  
    • ‘Translating’ business and engineering requirements for IT suppliers to realize IT solutions via changes and projects 
    • Development of MS SharePoint Site for Document Management and Knowledge Base for Key Users, delivered Workshops, Trainings and Onboarding Strategy
    Novartis AG
    Basel, Switzerland
    5 Monate
    2015-05 - 2015-09

    Senior IT Business Analyst with focus on Requirements Engineering and Test Management

    Document Management Software Project, Artwork Operations
    Document Management Software Project, Artwork Operations
    • Global Implementation of Documentum D2 for Document Management of Regulatory Artworks
    • Identify and create Business User Requirements within Workshops with Key Users to design the expected IT Solution
    • Design of Test Cases (PQ Testing) ensuring coverage of user requirements  
    • Authoring of Test Specifications  
    • Coordinate Test Execution with Subject Matter Experts  
    • Prepare and Conduct pre-go-live and post-go-live/ hypercare sessions taylored for the different end user groups of 800 users worldwide 
    Novartis AG
    Basel, Switzerland
    8 Monate
    2014-05 - 2014-12

    Business Transformation and Transition Project, Supply Chain Excellence, MRP II Class A

    Project Manager with focus on Change and Communication Managemen
    Project Manager with focus on Change and Communication Managemen
    • Leading the Transition of Master Data Management and Purchasing from Basel/Switzerland to Hyderabad/India in Pharma External Supply Organization
    • Accompany of NOSSCEE (Novartis Operational Standards for Supply Chain Excellence), Project to establish Global Supply Chain Excellence and KPI Reporting to target a MRP2 Class-A Certification, audited by Oliver Wright Company
    • Direct reports to Head of Supply Chain and Steering Committee: project charter, project plan, project report, status reports,  risk plan including targets, milestones, resources, cost, expenses
    • Business Process Analysis, Gap Analysis and Optimization 
    • Development of value-creation and harmonized processes within all involved functions: Quality, Supply Chain, Sourcing and Finance 
    • Stakeholder Management
    • Change Management, Change Communication 
    • Training Development, Training Coordination 
    • Leading the Transition of Master Data Management and Purchasing from Basel/Switzerland to Hyderabad/India in Pharma External Supply Organization
    • Accompany of NOSSCEE (Novartis Operational Standards for Supply Chain Excellence), Project to establish Global Supply Chain Excellence and KPI Reporting to target a MRP2 Class-A Certification, audited by Oliver Wright Company
    • Direct reports to Head of Supply Chain and Steering Committee: project charter, project plan, project report, status reports,  risk plan including targets, milestones, resources, cost, expenses
    • Business Process Analysis, Gap Analysis and Optimization 
    • Development of value-creation and harmonized processes within all involved functions: Quality, Supply Chain, Sourcing and Finance 
    • Stakeholder Management
    • Change Management, Change Communication 
    • Training Development, Training Coordination 

    Achievements:  

    • Improve Business Process including KPI Reporting of Master Data Management and Operational Sourcing to handover to new Master Data Team in Hyderabad/India (Business Process Offshoring/ Outsourcing) 
    • Delivered Change and Communication Strategy including Stakeholder Management 
    • Delivered Workshops, Trainings and Onboarding Strategy for new Master Data Team in India and all effected users and stakeholders 

    • Improve Business Process including KPI Reporting of Master Data Management and Operational Sourcing to handover to new Master Data Team in Hyderabad/India (Business Process Offshoring/ Outsourcing) 
    • Delivered Change and Communication Strategy including Stakeholder Management 
    • Delivered Workshops, Trainings and Onboarding Strategy for new Master Data Team in India and all effected users and stakeholders 
    Novartis AG
    Basel, Switzerland
    7 Monate
    2013-10 - 2014-04

    Change Control Project with Oracle Agile integration, Global Technical Operations, Supply Chain

    Project Quality Manager Computer System Validation, Document Man
    Project Quality Manager Computer System Validation, Document Man
    • Implementation of an integrated system based on Oracle Agile PLM to change control and support product information management of regulatory relevant information for Pharma 
    • Preparation of key Computerized System Validation documents, such as Validation Plan and Validation Report, conducting Quality Risk Assessment
    • Coordination of the preparation of documents by adequate stakeholders 
    • Management of the review, approval and implementation process of project deliverables 
    • Definition of the Tollgate Report, tracking of Tollgate deliverables 

    Achievements:  

    • Delivered Validation Strategy 
    • Delivered compliant system, no incidents 
    • Improved Project Documentation Management by implementing new concept for document archiving and approval process including Training for all writers and users 
    Novartis AG
    Basel, Switzerland
    6 Monate
    2013-05 - 2013-10

    SAP Data Migration Project, Supply Chain Management

    IT Business Analyst, SAP Data Migration Manager
    IT Business Analyst, SAP Data Migration Manager
    • Integration of API Drug Substance and SRM Strategic Raw Material business in one single SAP plant for Multimarket business and Switzerland in Pharma Supply Chain 
    • Development of the data migration methodology & implementation plan 
    • Development of best practice, processes and standards for effectively carrying out data migration activities 
    • Analysis, cleansing, harmonization and migration of data 
    • Coordination of testing activities 
    • Change Management, Change Communication 
    • Training Development, Training Coordination 

    Achievements:  

    • Delivered Migration and Cutover Strategy 
    • Assessed and delivered clean and proper Data for data migration activities 
    Novartis AG
    Basel, Switzerland
    5 Monate
    2012-12 - 2013-04

    Business Transformation Project with SAP SCM integration, Supply Chain Management

    Project Manager Change and Communication Management, Business Pr
    Project Manager Change and Communication Management, Business Pr
    • Establishment of Master Data Organization in External Supply Chain Management 
    • Establishment of Supply Data Manager job role 
    • Integration of MDM Team to ESO Organization 
    • Business and IT Process Analysis and Optimization 
    • Improvement of Standard Organization Procedures including process flows 
    • Training Development, Training Coordination  
    • Change Management, Change Communication 

    Achievements:  

    • Drive the organizational Change in Master Data Organization and make sure the functional solution fits to the global and local structures 
    • Delivered Change and Communication Strategy including Stakeholder Management 
    • Delivered Workshops and Trainings for users and stakeholders 
    Novartis AG
    Basel, Switzerland
    3 Monate
    2012-09 - 2012-11

    SAP ? New Plant Implementation Project, Supply Chain Management

    Project Manager Supply Master Data Management, Business Process
    Project Manager Supply Master Data Management, Business Process
    • Implementation of a new SAP plant to concentrate all business operations for multimarket and European external supply activities in Pharma External Supply Organization 
    • Leading the Workstream for Master Data Management
    • Direct reports to Head of Supply Chain and Steering Committee: project charter, project plan, project report, status reports, risk plan including targets, milestones, resources, cost, expenses
    • Business Process Analysis and Optimization 
    • Development of value-creation and harmonized processes within all involved functions: Quality, Supply Chain, Sourcing and Finance 
    • Change Management, Change Communication 
    • Training Management, Training Coordination 

    Achievements:  

    • Developed of Master Data Maintenance Strategy for Material, Vendor and Quality Master Data 
    • Delivered Concept for Master Data Governance 
    Novartis AG
    Basel, Switzerland
    5 Jahre 1 Monat
    2007-08 - 2012-08

    Various Projects & Clients

    Corporate Communication Manager, Public Relations Officer
    Corporate Communication Manager, Public Relations Officer
    • Consulting for Strategy, Conception, Campaigning, Branding, Public Relations, Online & Social Media Relations, Digital Marketing, Corporate and Web Design 
    • Social Media Management, Content Management, Journalism, Editorials 
    • Event Management, Incentives 
    • Art & Culture Management, Bookings and Promotion 

    Achievements:  

    • Developed Communication and Marketing strategies, that foster innovation in the digital space by adding cross-domain, cross-functional expertise on technology and business trends 
    • Reference Project: Developing and implement “VERSA” as digital avatar for VERSATEL to enforce Customer Relationship and Online Reputation Management on twitter, Facebook and diverse online forums (First Online Avatar in Germany) 
    Agency for Corporate Communication and Strategy, Corporate Branding, Public and Social Media Relations, Digital Marketing and Design
    Cologne, Germany
    6 Monate
    2012-02 - 2012-07

    Various Projects

    PMO Lead
    PMO Lead
    • PMO/Project Management Officer to Program Manager Product Design & Innovations, Telekom Innovation Labs, Virtualized Infrastructure & Global Cloud IT, User Experience Design 
    • Project Management for Design Transformation and Global Talent Management, Change Management, Change Communication, Concepts & Text, Design Thinking, Agile/Scrum 

    Achievements:  

    • Improve Talent Management Strategy to hire worldwide the most talented Designers for Deutsche Telekom Product Design 
    Deutsche Telekom AG
    Bonn, Germany
    1 Jahr 1 Monat
    2010-05 - 2011-05

    Various TV Projects

    Chief Editor/ TV-Journalism & TV-Production
    Chief Editor/ TV-Journalism & TV-Production
    • TV Editorial, TV Production, Television reports, features, magazines, RTL Punkt 12, RTL exklusiv, VOX prominent  

    Achievements:  

    • Developed TV-Production concept and editorial for TV-Features with ViPs like Topmodel Franziska Knuppe, Fashion Designer Talbot & Runhof and Guido Maria Kretschmar 
    RTL Television
    Cologne, Germany
    7 Monate
    2007-01 - 2007-07

    Various Projects

    Project Manager ? Online and Digital Marketing
    Project Manager ? Online and Digital Marketing
    • Online Editorials, Internet/Intranet Content Management (TYPO 3, JOOMLA), CRM, Social Media, Festivals and Incentives, Conception, Campaigning, Branding 

    Achievements 

    • Developed Sponsoring and Communication Concept for Love Parade Dortmund and other international Events and Festivals 
    • Developed new Micro-Website for Customer Services in TYPO 3 
    Virtual Nights Media Ltd
    Essen, Germany
    7 Monate
    2006-06 - 2006-12

    Various Projects

    • Project Management, Event Management, Incentives, Sponsoring, Product Placement in TV and Cinema movie productions, Online Editorials, Internet/Intranet Content Management, CRM, Social Media, Festivals and Incentives, Conception, Campaigning, Branding 

    Achievements:  

    • Increase the sells for Sponsoring and Customer Events over a 35 % during my procedure 
    • Delivered Marketing Strategy for Charity Golf Event of Deutsche Post and Kamps 
    Movie Art Marketing
    Dortmund, Germany

    Aus- und Weiterbildung

    Aus- und Weiterbildung

    5 Jahre 1 Monat
    2018-12 - 2023-12

    CLINICAL AND HEALTH PSYCHOLOGY

    B.Sc. CLINICAL AND HEALTH PSYCHOLOGY, SRH Riedlingen
    B.Sc. CLINICAL AND HEALTH PSYCHOLOGY
    SRH Riedlingen


    3 Jahre 2 Monate
    2020-05 - 2023-06

    Advanced Studies in Coaching

    DIPLOMA of Advanced Studies in Coaching, ZHAW, Insitute of Applied Psychology, Zurich
    DIPLOMA of Advanced Studies in Coaching
    ZHAW, Insitute of Applied Psychology, Zurich


    2 Jahre 7 Monate
    2020-05 - 2022-11

    CAS in Solution-focused Therapy and Counselling

    ZHAW, Insitute of Applied Psychology, Zurich
    ZHAW, Insitute of Applied Psychology, Zurich


    2 Jahre 5 Monate
    2019-03 - 2021-07

    Infromation Technology in Healthcare

    Master of Science, Donau Universität Krems
    Master of Science
    Donau Universität Krems
    9 Monate
    2019-06 - 2020-02

    ISO 27001 Certificate 

    ISO 27001 COMPLIANCE OFFICER & LEAD AUDITOR, Certificate , TÜV Rheinland
    ISO 27001 COMPLIANCE OFFICER & LEAD AUDITOR, Certificate 
    TÜV Rheinland
    1 Monat
    2018-09 - 2018-09

    HUMAN FACTORS/ USABILITY ENGINEERING (IEC 62366, IEC 60601, ISO 14971, FDA), Certificate

    Johner Institute, Konstanz
    Johner Institute, Konstanz
    1 Monat
    2018-06 - 2018-06

    MEDICAL DEVICE SOFTWARE DEVELOPMENT, VALIDATION AND VERIFICATION, Certificate

    Johner Institute, Konstanz
    Johner Institute, Konstanz
    1 Monat
    2018-05 - 2018-05

    IT AND CYBER SECURITY & DATA PROTECTION FOR MEDICAL DEVICES, Certificate 

    Johner Institute, Konstanz 
    Johner Institute, Konstanz 


    1 Monat
    2018-05 - 2018-05

    REGULATORY AFFAIRS FOR MEDICAL DEVICES, Certificate 

    Johner Institute, Konstanz 
    Johner Institute, Konstanz 


    7 Monate
    2017-10 - 2018-04

    REQUIREMENTS ENGINEERING FÜR BUSINESS ANALYSTEN, Certificate

    SGO Zürich 
    SGO Zürich 
    7 Monate
    2017-10 - 2018-04

    BPMN 2.0 BUSINESS PROCESS MODEL AND NOTATION, Certificate

    SGO Zürich
    SGO Zürich


    7 Monate
    2017-10 - 2018-04

    GROUP DYNAMICS, Certificate

    SGO Zürich
    SGO Zürich


    1 Monat
    2015-06 - 2015-06

    eREGULATORY AND INTELLIGENCE/ ISO IDMP

    Drug Information Association DIA, Philadelphia/ US 
    Drug Information Association DIA, Philadelphia/ US 
    1 Monat
    2014-06 - 2014-06

    OPERATIONAL SOURCING MANAGER SAP SCM/ Contract & Price Management in pharmaceutical industries

    OPERATIONAL SOURCING MANAGER, Novartis 
    OPERATIONAL SOURCING MANAGER
    Novartis 

    1 Monat
    2014-02 - 2014-02

    SYSTEMIC BUSINESS COACHING

    St. Galler Management Model, University of Applied Sciences: Technology, Business and Design, Wismar
    St. Galler Management Model, University of Applied Sciences: Technology, Business and Design, Wismar
    1 Monat
    2013-11 - 2013-11

    IT-Project Management & Computer System Validation in pharmaceutical industries

    CERT. PROJECT QUALITY MANAGER, Novartis
    CERT. PROJECT QUALITY MANAGER
    Novartis
    1 Monat
    2013-02 - 2013-02

    Supply Chain Data Management in pharmaceutical industries

    SUPPLY DATA MANAGER SAP SCM, Novartis
    SUPPLY DATA MANAGER SAP SCM
    Novartis
    1 Monat
    2013-02 - 2013-02

    CHANGE MANAGEMENT & ORGANIZATIONAL DEVELOPMENT

    CERT. SYSTEMIC CONSULTANT/ AGENT FOR CHANGE MANAGEMENT & ORGANIZATIONAL DEVELOPMENT, Alwart institute, Hamburg
    CERT. SYSTEMIC CONSULTANT/ AGENT FOR CHANGE MANAGEMENT & ORGANIZATIONAL DEVELOPMENT
    Alwart institute, Hamburg
    1 Monat
    2008-09 - 2008-09

    PUBLIC RELATIONS & PRESS OFFICE MANAGEMENT

    JOURNALIST FOR PUBLIC RELATIONS & PRESS OFFICE MANAGEMENT, German Institute for Publicity & Journalism, Hagen
    JOURNALIST FOR PUBLIC RELATIONS & PRESS OFFICE MANAGEMENT
    German Institute for Publicity & Journalism, Hagen
    1 Monat
    2002-06 - 2002-06

    BUSINESS ADMINISTRATION Apprenticeship

    MANAGEMENT ASSISTANT BUSINESS ADMINISTRATION Apprenticeship, Volkswagen/Audi, Dortmund
    MANAGEMENT ASSISTANT BUSINESS ADMINISTRATION Apprenticeship
    Volkswagen/Audi, Dortmund
    1 Monat
    1999-06 - 1999-06

    BUSINESS ADMINISTRATION

    DIPLOMA IN BUSINESS ADMINISTRATION, Commercial High School, Unna
    DIPLOMA IN BUSINESS ADMINISTRATION
    Commercial High School, Unna


    Kompetenzen

    Kompetenzen

    Top-Skills

    Digital Health Quality Management Computer System Validation ISO 27001 DIN EN ISO 13485 IEC 62304 Auditor Requirement Engineer Business Analyst Business Process Modeling 21 CFR Part 820 Agile Softwareentwicklung Software as a Medical Device SaMD ISO 14971 Software Lifecycle IT Security nach BSI GAMP Biotechnology GMP 21 CFR cloud transformation SAP HANA IaaS

    Aufgabenbereiche

    Audit Management
    Business Analysis
    Digital Health Solutions
    GAMP 5 Computer Software Validieren
    IEC 62304
    ISO13485
    Qualitätsmanagement (Einführung...)
    Requirements Engineering
    Software as a Medical Device
    Usability Engineering

    Produkte / Standards / Erfahrungen / Methoden

    Application Lifecycle Management
    ARIS Plattform
    Atlassian Confluence
    Atlassian JIRA Agile
    Bio-Technologie
    Business Process Analysis
    Change Management
    Complaint Management
    Documentum D2
    Good Laboratory Practice
    ISO 27001
    Knowledge Management
    Labware
    RequirementEngineering
    SAP ERP
    SAP SolMan
    Werum IT Solutions

    Industry Standards and Methods:

    ISO (ISO-9000 and 14971),  GAMP5


    Regulations:

    • ICH, FDA, WHO, EMA
    • Annex/Part 11, predicate GLP, GCP, GMP rules
    • ISO IDMP, eCTD


    Office Applications:

    • MS Office (Excel, Word, PowerPoint, SharePoint, Visio, Project), Outlook, SharePoint
    • Mac iWork, Mac Mail
    • IBM Lotus Notes


    Skills:

    • Master of Science in Information Technology in Healthcare
    • IT Security Officer & Auditor for ISO 27001 (TÜV), Cyber Security ISACA/ BSI
    • Business Analyst & Requirements Engineer (IREB, UX, Human Centered Design)
    • IT Quality & Regulatory Compliance Auditor (GxP, EMA, FDA)
    • Quality Management System Expert (Pharmaceutical, Biotechnology, Medical Devices, Healthcare)
    • Computer System Validation & Software Verification Specialist (Digital Health Solutions, GAMP 5, FDA CSA)
    • SaFe Scrum Master, Coach & Organizational Change Manager (ZHAW IAP)


    Profile:

    • Her heart has been beating for lean and effective quality management in the medical technology, biotechnology and pharmaceutical industry for over 15 years. She is passionate about new technologies for digital transformation in healthcare, from Digital Health Platforms to Health Apps/ Software as a Medical Device to GxP compliant computer systems for business process automation
    • She accompanies medical technology start-ups and SMEs in the development and introduction of digital product innovations. For this purpose, she has designed her own regulatory roadmap from her years of experience in the pharmaceutical industry, biotechnology and medical technology, which promises a product launch within 12 months. This "fast track" begins with the generation of ideas, through the establishment of a quality management system and technical documentation, to the market launch. It also includes building a digital integrated ecosystem with cutting-edge technologies
    • She also has more than 18 years of experience in global corporate roles and multicultural and multidisciplinary IT and business transformation projects and programs with extensive expertise and professional experience in regulated environments. In doing so, she leads nearshore and offshore teams in multiple locations
    • She is known as an Excellent Writer, Presenter and Facilitator for global projects with large audiences, customer focused, always motivated to exceed expectations and go the extra mile


    Provided Consulting Services are:

    • Digital Transformation in Healthcare & Life Science, Digitalization of business processes and modern IT architecture
    • Regulatory Compliance and Audits within Pharmaceuticals and Medical Device industry (GxP, EMA, FDA, PIC/S, ISO, MDR, ICH)
    • Quality Management and Assurance for Software Development of Digital Health Solutions, Medical Device Software, Software as a Medical Device and Computerized Systems (ISO 13485, FDA 820)
    • Computer System & Software Validation and Verification (IEC 62304/ 82304, GAMP 5 2nd Edition/CSV, FDA CSA)
    • Electronic Records & Signatures/ ERES (Annex 11, Part 11)
    • Data Integrity, Data Governance & Migration
    • Quality & Product Risk Management (FMEA, ISO 14971)
    • Information & Cyber Security Management ISO 27001 TÜV SÜD certified Compliance Officer, ISACA/BSI certified Cyber Security Practioner
    • Business Analysis and Requirements Engineering (BABOK, IREB)
    • Usability & User Experience, Human-Centered Design (UXQB, IEC 62366)
    • Business Process Modeling & Transformation, BPMN 2.0
    • Digital and Mobile Solutions Development, Cloud Solutions, Data Repository, Digital Health Platforms (IoT), Digital Therapeutics DTx, DIGA, Digital Health Apps, SaMD Software as a Medical Device
    • Systemic Organizational Development, Change and Communication Management
    • Business Coaching (St. Galler Management Model, Systemic Coaching, solution-resource oriented Counselling, Hypnotherapy, Introvision etc.)
    • Agile & Lean Methods, SAFe Scrum Master
    • Project Management & Facilitator


    Primary Expertise:

    • Quality Management and Assurance for Software Development of Medical Device Software and Computerized Systems
    • Regulatory Compliance and Audits within Pharmaceuticals and Medical Device industry (EMA, FDA, PIC/S, ISO, MDD/MDR, ISO)
    • Quality Risk Management (FMEA, ISO 14971)
    • Software Validation and Verification (IEC 623304/82304, GAMP 5/CSV)
    • Business Analysis/ Requirements and Usability Engineering (BABOK, IREB, IEC 62366)
    • Information Security Management ISO 27001


    Related Experience:

    • Digital Health (SaMD)
    • Cloud Solutions/ Mobile Applications
    • Information & Data Security, Data Integrity, Data Privacy
    • Project Management/ Agile Methodology/ Scrum
    • Business Process Modeling & Transformation, BPMN 2.0
    • Change and Communication Management/ Training and Coaching, Workshops
    • Master Data Governance, Data and Migration Management
    • MRP II Class A/ Business Excellence/ Oliver Wight
    • ITIL V3 Foundation
    • Good Documentation and Technical Writing Skills


    Client List:

    • Air Liquide, Düsseldorf/DE
    • Abbot, Hannover/DE
    • Möller Medical Fulda/DE
    • BioNTech
    • Beiersdorf AG, Hamburg/DE
    • EKF Diagnostics Barleben/DE Telefónica, Düsseldorf/DE
    • Karl Storz, Tuttlingen/DE
    • LONZA, Basel/CH
    • Sanofi Aventis, Frankfurt/DE, US
    • Camlog/Altatec, Basel/CH, Wimsheim/DE
    • Sutter Medizintechnik, Freiburg/DE
    • Fresenius Kabi SwissBioSim, Eysin/CH
    • Fresenius Kabi Digital Lab, Berlin/DE
    • Fresenius Kabi, Germany, Switzerland, Italy, Spain, South America
    • Novartis Pharma, Basel/CH, US, Dublin/IR, Stein/CH
    • Deutsche Telekom, Bonn/DE
    • Evonik (Degussa) AG, Düsseldorf/DE
    • RWE AG, Essen/DE


    Business Software, Hardware, Firmware:

    • Philips HealthSuite digital platform
    • BrightInsight Digital Health Platform - Internet of Things platform for BioPharma and MedTech
    • Laboratory Systems: Perkin Elmer, eLN and Spotfire, Labware LIMS, BIOVIA, D-Wise CAP SAS, Thermo Fisher Chromeleon, Rotronic Monitoring System RMS
    • ITSM IT Service Management ? BMC Remedy ITSM Suite, SAP NetWeaver, SAP Solution Manager, Service Now
    • Service Now Discovery for IT Infrastructure
    • JIRA Service Desk for IT Demand Management and Software Development
    • CONFLUENCE Content Collaboration-Software
    • ERP ? SAP SCM, MM-PUR, WM, PP, PM Plant Maintenance, MMP Procurement (Material Management) incl. all objects: BOM, PR, SL, Contract and Purchase Order, Order Fulfillment (Sales Order Management), Vendor Master Data (including SIM Tool authorization), Quality Master Data, R/3 HR, ESS
    • SAP Hana Cloud (Application for Digital Home & Healthcare)
    • MES Manufacturing Execution Systems (ATLAS, PAS-X, PMX, Rockwell), MMC Material Movement Controller
    • ALM & Test Management - HP Quality Center/ PROTON Test Software, SAP Solution Manager (Implementation, Test Workbench)
    • BPM Business Process Modelling ? ARIS
    • CMS Content Management ? Vignette, Microsoft Office SharePoint Server (ECM), MODx, TYPO3, Wordpress, HTML
    • Document Management - Documentum D2 and Life Science Suite, Veeva, Microsoft SharePoint
    • CRM Customer Relationship Management ? Mamis (Deloitte), vtiger, Daylite, salesforce
    • Project Management - Microsoft Project, Biquanda (ehem. OpenTime), Open Workbench, Sciforma, Project Scheduler, GRANEDA Dynamic, GANTT project, MindManager

    Programmiersprachen

    Business Process Modeling Notation

    Hardware


      Design / Entwicklung / Konstruktion

      agiles Projektmanagement
      Conception
      Data Quality
      Data-Migration
      FMEA
      Requirement Analyse

      Managementerfahrung in Unternehmen

      Auditor
      Computer System Validation
      GxP-Compliance
      Qualitätsicherung
      Software Lifecycle
      Software Quality Assurance

      Interim Management and Leadership:

      • Quality and Compliance Manager
      • Change and Transformation Manager
      • IT Project Manager, Business Analyst/ Engineer

      Branchen

      Branchen

      • Regulated Industry
      • Pharmaceutical
      • Medical Device
      • BioTech
      • Med Tech

      Vertrauen Sie auf GULP

      Im Bereich Freelancing
      Im Bereich Arbeitnehmerüberlassung / Personalvermittlung

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