• 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

Service Delivery and direct report to Head of Innovation and Development

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

• 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.)

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.)

Service Delivery and direct report to Head of Global Digitalization Projects

• 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

Consulting services for the preparation of technical documentation for EKF Link

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

• 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

• 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

Service Delivery and direct report to Head of IT

Service Delivery and direct report to Quality Head and Program Lead

Service Delivery and direct report to Quality Assurance and Product Owner

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)

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

• 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

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

• 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

• 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

• 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

• 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

• 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 

• 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 

• 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 

• 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 

• 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 

• 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 

• 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) 

• 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 

• 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 

• 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 

• 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