Goal-oriented, results-driven IT Quality, CSV & Risk Management professional with 10 years of international experience within Pharma & Medical Device
Aktualisiert am 02.02.2023
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 02.02.2023
Verfügbar zu: 100%
davon vor Ort: 100%
Data Integrity
CSV
Projekt Management (SCRUM & Traditionell)
GAMP 5
SOP Creation, Review & Approval
Data Integrity Strategy & Gap Assessment (ALCOA)
Audit Preparation / Regulatory Compliance
FDA 21 CFR Part 11, 211, 212, 820
MHRA, EMA, PDA, WHO, FDA Guidelines re: Data Integrity
GxP (GCP , GDP , GMP , GLP)
Electronic Records/ Electronic Signatures (21 CFR, Part 11)
ENGLISH
Professional proficiency
FRENCH
Basic proficiency
German
Native proficiency
SPANISH
Advanced proficiency

Einsatzorte

Einsatzorte

Deutschland, Österreich, Schweiz
möglich

Projekte

Projekte

3 Jahre 11 Monate
2020-04 - heute

Develop Data Integrity strategy

Data Integrity Strategy Advisor, Medical Devices ISO 13485/ MDR
Data Integrity Strategy Advisor, Medical Devices ISO 13485/ MDR
  • Develop Data Integrity strategy and respective SOP and attachments
  • Creation of templates for Data Integrity Gap Assessments, Data Integrity Risk Catalogue and Data Integrity Self-Inspection checklist for production processes
  • Training of project team on Data Integrity & respective documentation
  • Service Delivery as direct report to Head of Quality Management
Karl Storz, Tuttlingen (Germany) / remote
4 Jahre 11 Monate
2019-04 - heute

expertise for development and implementation of role-based data integrity

Senior Consultant & Head of Product Development
Senior Consultant & Head of Product Development
  • Project execution for different clients within the life science industry
  • Team lead, training and development of junior consultants
  • Head of Product Development Department: Built up department & respective processes; responsible for new product development (CSV, QMS, SaMD) incorporating design-thinking methodology
  • Provide subject matter expertise for development and implementation of role-based data integrity and CSV training
Digital Chameleon GmbH, various clients (see following positions)
8 Monate
2020-02 - 2020-09

Develop global strategy for Qualification and Validation

Consultant
Consultant

Quality & Compliance Strategy Consultant of Digital Health Systems, Software as a Medical Device (SaMD) and Digital Health Platform

Tasks:

  • Develop global strategy for Qualification and Validation of Digital Health Platforms used for medicinal and GxP-relevant data (PaaS, SaaS)
  • CSV/ Validation Responsible during Supplier Assessment for PaaS
  • Validation Lead as Project Quality Manager for Digital Health Platforms incl. formulation of VMP
Novartis Pharma, TRD and NBS, Basel/CH, remote
10 Monate
2019-10 - 2020-07

FDA Pre-Approval Inspection Readiness Program

Project Lead
Project Lead
  • Lead the Project for the Preparation and Execution for FDA Pe-Approval Inspection for Commercial Manufacturing (DS/DP for Molecules and Antibodies) to comply with all inspectional objectives
  • Conduct Pre-Inspections within Analytical Labs (GMP, GLP) and train Quality Team for PAI audit
  • Evaluate and mitigate gaps for compliance of FDA PAI objectives for the new Quality System for Commercial Manufacturing, i.e. Data Integrity, Computer System Validation
  • Review, update & creation of process documentation (Global and local SOPs & templates) according to FDA requirements
Lonza, Basel (Switzerland)
2 Monate
2019-08 - 2019-09

Controlling, monitoring and improving

Quality & Compliance ? CSV Consultant
Quality & Compliance ? CSV Consultant
  • Optimization of vendor management process including creation of respective documentation
  • Controlling, monitoring and improving the implementation of the validation process for R&D computer systems according to GLP, GCP, GVP; specifically, development of various templates for Life Cycle documentation
  • Consulting in quality management, especially in quality risk management, quality risk assessment and ad hoc quality control
Merck Healthcare KGaA, Darmstadt (Germany)
3 Monate
2019-06 - 2019-08

Service Delivery and direct report to Head of Quality

Quality and Compliance/ CSV Strategy Consultant
Quality and Compliance/ CSV Strategy Consultant
  • Conduct Audit and Inspection Readiness for MDR in the area of Computer System Validation
  • Provide strategic advice in creating a Corporate Framework within existing QMS 13485 for Computer System Validation, implementing a corporate procedure for CSV including templates for validation management
  • Implementing CSV Strategy into ITIL processes within IT Department
  • Formulate Validation Strategy for current IT Systems as part of the QMS, fulfilling requirements from FDA (820.20, Part 11), Annex 11 and ISO 13485, execution of all validation activities and documentation
  • Develop Validation Lifecycle Documentation and Templates, i.e. Validation Plan, Test Plan, Validation Report (German and English documentation)
Altatec GmbH, Basel (Switzerland) & Wimsheim (Germany)
2 Monate
2019-05 - 2019-06

Service Delivery and direct report to Head of Quality

Quality and Compliance/ CSV Strategy Consultant
Quality and Compliance/ CSV Strategy Consultant
  • Creating concept for Validation Strategy for the Re-validation of current IT Systems as part of the QMS, fulfilling requirements from FDA (820.20, Part 11), Annex 11 and ISO 13485, execution of all validation activities and documentation
  • Support in strategy and advice to establish and improve a Corporate Framework within existing QMS 13485 for Computer System Validation, implementing a corporate procedure for CSV including templates for validation management
Sutter Medizintechnik, Freiburg (Germany)
2 Monate
2019-04 - 2019-05

Audit Preparation, Desktop Audit

Auditor for IT Supplier Audit (GMP, CSV, Data Integrity)
Auditor for IT Supplier Audit (GMP, CSV, Data Integrity)
  • Auditing an IT Supplier and its Cloud Solution for Clinical Trial Analytics and Data Management (SAS)
  • Audit Preparation, Desktop Audit (Document Review), Onsite Audit at Data Center and Quality Department, manage audit response with Supplier
  • Create Audit Plan and Report, follow up on Audit Closure
D-Wise (Manchester, UK) for Fresenius Kabi
2 Monate
2019-04 - 2019-05

Realization of Validation Strategy

Quality and Compliance/ CSV Strategy Consultant, eDMS Migration
Quality and Compliance/ CSV Strategy Consultant, eDMS Migration
  • Realization of Validation Strategy for the Development and Implementation of local and global IT Systems for Document Management (Documentum D2 for eTMF, eCTD, Submission Management, R&D) and Data Handling (eLN, Rotronic RMS) within the Research & Development Laboratory
  • Providing strategy and advice to establish a Corporate Framework for Project Governance of Computer System Validation and Equipment Qualification during Laboratory Relocation
Fresenius Kabi SwissBioSimiliar, Eysin, CH
9 Monate
2018-08 - 2019-04

LIMS (LabWare) Implementation

Project Manager
Project Manager
  • In charge of the full range of all Project Management tasks for implementation of LIMS at Düsseldorf (Holthausen) site to ensure full reflection of user needs
  • Leadership of the project team (23 team members)
  • Review of validation plan, risk analysis and validation report
  • Accountable that all plans reflect management expectations and keep all plans up to date
  • Coordination of project team activities
  • Assurance that released validation and qualification reports / conditional release documents are created and approved as prerequisite for the Go Live
BASF Personal Care and Nutrition GmbH
2 Jahre 11 Monate
2016-06 - 2019-04

International project execution and support

Senior Life Science Consultant & Manager
Senior Life Science Consultant & Manager
  • International project execution and support for different clients within the life science industry (see following positions) for IT Quality & Compliance and Project Management
  • Team lead, training and development of junior consultants
  • Provide subject matter expertise for development and implementation of role-based data integrity and CSV training as required
  • Development of extensive templates and guidance for lifecycle documentation
KVALITO Consulting Group, Various clients (see following positions)
5 Monate
2018-04 - 2018-08

CSV Global Remediation Quality Project

Senior Manager
Senior Manager
  • Actelion GxP Compliance Analysis, Gap Assessment and Remediation
  • Ensuring J&J Quality standards are applied to Actelion processes and documentation
  • Validation of a large number of applications – Following SDLC Application Track
  • Multi-Site / Cross-functional remediation; applying J&J quality standards on Actelion processes and documentation
Actelion (Johnson & Johnson Group)
7 Monate
2017-09 - 2018-03

Management, coordination and execution of Data Integrity Gap Assessments

Data Integrity Risk Manager
Data Integrity Risk Manager
  • Management, coordination and execution of Data Integrity Gap Assessments and Data Maps (data flow diagrams) to identify Data Integrity risks for all Drug Substance production processes in close alignment with Quality Department and definition / suggestion of respective CAPAs by applying ALCOA principle
  • Development of efficient and FDA-compliant Data Integrity solution to meet project / regulatory requirements within very demanding deadline
  • Harmonization of documents and alignment with project work streams (equipment, computer systems, lab processes) to ensure global implementation approach
  • Audit / client assessment preparation to achieve and maintain Data Integrity compliance within current GMP and regulatory requirements
Boehringer Ingelheim (Biberach a.d. Riß, Germany)
1 Jahr 2 Monate
2016-08 - 2017-09

Planning and implementation

Global Validation & Quality Manager
Global Validation & Quality Manager
  • Global Quality & System Compliance, Global IT and Business Transformation, global rollout of harmonized SAP and MES
  • Planning and implementation of all Computer System Validation activities including its documentation according to business and regulatory requirements (incl. GAMP5)
  • Validation & Quality Manager at Fresenius Kabi for Global IT harmonization project (SAP p11 roll-out) and MES system
  • Ensure that global computer system validation strategy is effectively implemented for all GxP systems and that they remain compliant throughout their lifecycle
  • Execution and coordination of initial and detailed GxP risk assessments and analysis regarding regulations, policies, standards and scientific literature (FDA,WHO,ICH)
  • Monitor risks and deviations related to GxP computerized systems and computer system validation to ensure gaps are identified, adequately addressed and documented
  • Execution and coordination of testing (IQ, OQ, PQ)
  • Development and maintenance of requirements traceability matrix to ensure compliance
  • On-site validation support of project pilot countries (Italy, Poland, Puerto Rico, Dominican Republic) including provision of validation documents
  • Providing Computer System Validation training and Data Integrity Training (incl. template) to global project team
  • Advice and support to system owners to build and maintain GxP, Data Privacy and Integrity and IT Security conform systems
Fresenius Kabi (Bad Homburg, Germany)
1 Jahr 7 Monate
2014-11 - 2016-05

Monitoring, analyzing and communicating key reimbursement

Analyst, Health Policy & Reimbursement
Analyst, Health Policy & Reimbursement
  • Monitoring, analyzing and communicating key reimbursement and FDA regulation & current guidance documents relevant to Roche business
  • Engaged in and reported on various federal institutions, trade organizations ad hoc industry coalitions (e.g., AdvaMed, the American Medical Association, the Centers for Medicare and Medicaid Services) on behalf of Roche Diagnostics
  • Roll-Out of Customer Support Tool to identify coding & payment of Roche FDA-approved tests
  • Provision of Health Policy training to Sales & Marketing Teams
  • Design and implementation of web-based trainings regarding the Reimbursement environment of Tissue and Point-of-Care Diagnostics
  • Provision of internal and external customer support on Medicare & Medicaid issues for all Business Units
  • Development of extensive reimbursement guides for each Business Unit of the organization
Roche Diagnostics Corporation (Washington DC, USA)

Aus- und Weiterbildung

Aus- und Weiterbildung

2 Jahre 1 Monat
2018-02 - 2020-02

MBA, Business Management

MBA, Business Management, ESEI International Business School Barcelona (Barcelona, Spain
MBA, Business Management
ESEI International Business School Barcelona (Barcelona, Spain

Kompetenzen

Kompetenzen

Top-Skills

Data Integrity CSV Projekt Management (SCRUM & Traditionell) GAMP 5 SOP Creation, Review & Approval Data Integrity Strategy & Gap Assessment (ALCOA) Audit Preparation / Regulatory Compliance FDA 21 CFR Part 11, 211, 212, 820 MHRA, EMA, PDA, WHO, FDA Guidelines re: Data Integrity GxP (GCP , GDP , GMP , GLP) Electronic Records/ Electronic Signatures (21 CFR, Part 11)

Produkte / Standards / Erfahrungen / Methoden

OVERVIEW

  • Dynamic professional with agile-digital mindset with 10 years of global experience within the life science industry in various positions (Europe & United States)
  • Extensive experience in the IT Quality & Compliance Management field within the Pharmaceutical and Medical Device industry as consultant and employee for major life science companies (Roche Diagnostics, Fresenius, Boehringer Ingelheim, Johnson & Johnson, Merck, Henry Schein Group, BASF, Lonza, Novartis)
  • Computer System Validation, Data Integrity and Risk Management (FMEA)
  • GxP Compliance: audit / assessment preparation (for regulatory authorities and clients)
  • Global Project Management experience and leading of onshore and off-shore teams (Europe & United States)
  • Expertise in US Health Policy, Reimbursement and Market Access. Multiple years for Roche in Washington, DC
  • Global work experience in the United States and Europe enable me to excel in a multicultural environment. Working across cultures within the healthcare industry has provided me with keen insights and an understanding to communicate not only in different languages but also to understand different cultures and to act accordingly

PROFESSIONAL EXPERTISE

  • Computer System Validation (CSV) according to GAMP 5
  • Project Management (SCRUM & Traditional)
  • Global and local SOP Creation, Review & Approval
  • Data Integrity Strategy & Gap Assessment (ALCOA)
  • Audit Preparation / Regulatory Compliance within Pharmaceuticals and Medical Device industry
  • FDA 21 CFR Part 11, 211, 212, 820
  • MHRA, EMA, PDA, WHO, FDA Guidelines re: Data Integrity
  • GxP (GCP, GDP, GMP, GLP)
  • Electronic Records/ Electronic Signatures (21 CFR, Part 11)

EMPLOYERS & CLIENTS AS CONSULTANT

Employers:

  • Roche Diagnostics Corporation, United States
  • Roche Diagnostics, Germany
  • KVALITO Consulting Group
  • Digital Chameleon Consulting Group

Clients:

  • Fresenius Kabi, Germany
  • Fresenius Hemo Care Italia
  • Boehringer-Ingelheim, Germany
  • BASF Personal Care and Nutrition GmbH
  • Sutter Medizintechnik, Freiburg/DE
  • Fresenius Kabi Swiss BioSim, Eysin/CH
  • Altatec GmbH, Basel/CH, Wimsheim/DE
  • Merck Healthcare KGaA
  • Lonza, Switzerland
  • Novartis, Switzerland

COMPETENCIES

Regulations

  • FDA CFR Part 11, 211, 212, 820
  • EU GMP ? Annex 11
  • ISO 13485, ISO 14971, ISO 27001, ISO 9001
  • MHRA, EMA, PDA, WHO, FDA Guidelines re: Data Integrity
  • GxP (GCP, GDP, GMP, GLP)
  • Medicare & Medicaid (Centers for Medicare & Medicaid Services) regulations

Business Software, Hardware, Firmware

  • 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), Quality Master Data
  • SAP Hana Cloud (Application for Digital Home & Healthcare)
  • MES Manufacturing Execution Systems (PAS-X, PMX), Werum solutions
  • Test Management - HP Quality Center/ PROTON Test Software, SAP Solution Manager (Implementation, Test Workbench)
  • BPM Business Process Modelling ? ARIS, MS Visio (Data Flow Modelling)
  • CMS Content Management ?Microsoft Office SharePoint Server (ECM), Wordpress, HTML
  • Document Management - Documentum D2 and Life Science Suite, Veeva, Microsoft SharePoint
  • CRM Customer Relationship Management ? salesforce, Microsoft Dynamics

Einsatzorte

Einsatzorte

Deutschland, Österreich, Schweiz
möglich

Projekte

Projekte

3 Jahre 11 Monate
2020-04 - heute

Develop Data Integrity strategy

Data Integrity Strategy Advisor, Medical Devices ISO 13485/ MDR
Data Integrity Strategy Advisor, Medical Devices ISO 13485/ MDR
  • Develop Data Integrity strategy and respective SOP and attachments
  • Creation of templates for Data Integrity Gap Assessments, Data Integrity Risk Catalogue and Data Integrity Self-Inspection checklist for production processes
  • Training of project team on Data Integrity & respective documentation
  • Service Delivery as direct report to Head of Quality Management
Karl Storz, Tuttlingen (Germany) / remote
4 Jahre 11 Monate
2019-04 - heute

expertise for development and implementation of role-based data integrity

Senior Consultant & Head of Product Development
Senior Consultant & Head of Product Development
  • Project execution for different clients within the life science industry
  • Team lead, training and development of junior consultants
  • Head of Product Development Department: Built up department & respective processes; responsible for new product development (CSV, QMS, SaMD) incorporating design-thinking methodology
  • Provide subject matter expertise for development and implementation of role-based data integrity and CSV training
Digital Chameleon GmbH, various clients (see following positions)
8 Monate
2020-02 - 2020-09

Develop global strategy for Qualification and Validation

Consultant
Consultant

Quality & Compliance Strategy Consultant of Digital Health Systems, Software as a Medical Device (SaMD) and Digital Health Platform

Tasks:

  • Develop global strategy for Qualification and Validation of Digital Health Platforms used for medicinal and GxP-relevant data (PaaS, SaaS)
  • CSV/ Validation Responsible during Supplier Assessment for PaaS
  • Validation Lead as Project Quality Manager for Digital Health Platforms incl. formulation of VMP
Novartis Pharma, TRD and NBS, Basel/CH, remote
10 Monate
2019-10 - 2020-07

FDA Pre-Approval Inspection Readiness Program

Project Lead
Project Lead
  • Lead the Project for the Preparation and Execution for FDA Pe-Approval Inspection for Commercial Manufacturing (DS/DP for Molecules and Antibodies) to comply with all inspectional objectives
  • Conduct Pre-Inspections within Analytical Labs (GMP, GLP) and train Quality Team for PAI audit
  • Evaluate and mitigate gaps for compliance of FDA PAI objectives for the new Quality System for Commercial Manufacturing, i.e. Data Integrity, Computer System Validation
  • Review, update & creation of process documentation (Global and local SOPs & templates) according to FDA requirements
Lonza, Basel (Switzerland)
2 Monate
2019-08 - 2019-09

Controlling, monitoring and improving

Quality & Compliance ? CSV Consultant
Quality & Compliance ? CSV Consultant
  • Optimization of vendor management process including creation of respective documentation
  • Controlling, monitoring and improving the implementation of the validation process for R&D computer systems according to GLP, GCP, GVP; specifically, development of various templates for Life Cycle documentation
  • Consulting in quality management, especially in quality risk management, quality risk assessment and ad hoc quality control
Merck Healthcare KGaA, Darmstadt (Germany)
3 Monate
2019-06 - 2019-08

Service Delivery and direct report to Head of Quality

Quality and Compliance/ CSV Strategy Consultant
Quality and Compliance/ CSV Strategy Consultant
  • Conduct Audit and Inspection Readiness for MDR in the area of Computer System Validation
  • Provide strategic advice in creating a Corporate Framework within existing QMS 13485 for Computer System Validation, implementing a corporate procedure for CSV including templates for validation management
  • Implementing CSV Strategy into ITIL processes within IT Department
  • Formulate Validation Strategy for current IT Systems as part of the QMS, fulfilling requirements from FDA (820.20, Part 11), Annex 11 and ISO 13485, execution of all validation activities and documentation
  • Develop Validation Lifecycle Documentation and Templates, i.e. Validation Plan, Test Plan, Validation Report (German and English documentation)
Altatec GmbH, Basel (Switzerland) & Wimsheim (Germany)
2 Monate
2019-05 - 2019-06

Service Delivery and direct report to Head of Quality

Quality and Compliance/ CSV Strategy Consultant
Quality and Compliance/ CSV Strategy Consultant
  • Creating concept for Validation Strategy for the Re-validation of current IT Systems as part of the QMS, fulfilling requirements from FDA (820.20, Part 11), Annex 11 and ISO 13485, execution of all validation activities and documentation
  • Support in strategy and advice to establish and improve a Corporate Framework within existing QMS 13485 for Computer System Validation, implementing a corporate procedure for CSV including templates for validation management
Sutter Medizintechnik, Freiburg (Germany)
2 Monate
2019-04 - 2019-05

Audit Preparation, Desktop Audit

Auditor for IT Supplier Audit (GMP, CSV, Data Integrity)
Auditor for IT Supplier Audit (GMP, CSV, Data Integrity)
  • Auditing an IT Supplier and its Cloud Solution for Clinical Trial Analytics and Data Management (SAS)
  • Audit Preparation, Desktop Audit (Document Review), Onsite Audit at Data Center and Quality Department, manage audit response with Supplier
  • Create Audit Plan and Report, follow up on Audit Closure
D-Wise (Manchester, UK) for Fresenius Kabi
2 Monate
2019-04 - 2019-05

Realization of Validation Strategy

Quality and Compliance/ CSV Strategy Consultant, eDMS Migration
Quality and Compliance/ CSV Strategy Consultant, eDMS Migration
  • Realization of Validation Strategy for the Development and Implementation of local and global IT Systems for Document Management (Documentum D2 for eTMF, eCTD, Submission Management, R&D) and Data Handling (eLN, Rotronic RMS) within the Research & Development Laboratory
  • Providing strategy and advice to establish a Corporate Framework for Project Governance of Computer System Validation and Equipment Qualification during Laboratory Relocation
Fresenius Kabi SwissBioSimiliar, Eysin, CH
9 Monate
2018-08 - 2019-04

LIMS (LabWare) Implementation

Project Manager
Project Manager
  • In charge of the full range of all Project Management tasks for implementation of LIMS at Düsseldorf (Holthausen) site to ensure full reflection of user needs
  • Leadership of the project team (23 team members)
  • Review of validation plan, risk analysis and validation report
  • Accountable that all plans reflect management expectations and keep all plans up to date
  • Coordination of project team activities
  • Assurance that released validation and qualification reports / conditional release documents are created and approved as prerequisite for the Go Live
BASF Personal Care and Nutrition GmbH
2 Jahre 11 Monate
2016-06 - 2019-04

International project execution and support

Senior Life Science Consultant & Manager
Senior Life Science Consultant & Manager
  • International project execution and support for different clients within the life science industry (see following positions) for IT Quality & Compliance and Project Management
  • Team lead, training and development of junior consultants
  • Provide subject matter expertise for development and implementation of role-based data integrity and CSV training as required
  • Development of extensive templates and guidance for lifecycle documentation
KVALITO Consulting Group, Various clients (see following positions)
5 Monate
2018-04 - 2018-08

CSV Global Remediation Quality Project

Senior Manager
Senior Manager
  • Actelion GxP Compliance Analysis, Gap Assessment and Remediation
  • Ensuring J&J Quality standards are applied to Actelion processes and documentation
  • Validation of a large number of applications – Following SDLC Application Track
  • Multi-Site / Cross-functional remediation; applying J&J quality standards on Actelion processes and documentation
Actelion (Johnson & Johnson Group)
7 Monate
2017-09 - 2018-03

Management, coordination and execution of Data Integrity Gap Assessments

Data Integrity Risk Manager
Data Integrity Risk Manager
  • Management, coordination and execution of Data Integrity Gap Assessments and Data Maps (data flow diagrams) to identify Data Integrity risks for all Drug Substance production processes in close alignment with Quality Department and definition / suggestion of respective CAPAs by applying ALCOA principle
  • Development of efficient and FDA-compliant Data Integrity solution to meet project / regulatory requirements within very demanding deadline
  • Harmonization of documents and alignment with project work streams (equipment, computer systems, lab processes) to ensure global implementation approach
  • Audit / client assessment preparation to achieve and maintain Data Integrity compliance within current GMP and regulatory requirements
Boehringer Ingelheim (Biberach a.d. Riß, Germany)
1 Jahr 2 Monate
2016-08 - 2017-09

Planning and implementation

Global Validation & Quality Manager
Global Validation & Quality Manager
  • Global Quality & System Compliance, Global IT and Business Transformation, global rollout of harmonized SAP and MES
  • Planning and implementation of all Computer System Validation activities including its documentation according to business and regulatory requirements (incl. GAMP5)
  • Validation & Quality Manager at Fresenius Kabi for Global IT harmonization project (SAP p11 roll-out) and MES system
  • Ensure that global computer system validation strategy is effectively implemented for all GxP systems and that they remain compliant throughout their lifecycle
  • Execution and coordination of initial and detailed GxP risk assessments and analysis regarding regulations, policies, standards and scientific literature (FDA,WHO,ICH)
  • Monitor risks and deviations related to GxP computerized systems and computer system validation to ensure gaps are identified, adequately addressed and documented
  • Execution and coordination of testing (IQ, OQ, PQ)
  • Development and maintenance of requirements traceability matrix to ensure compliance
  • On-site validation support of project pilot countries (Italy, Poland, Puerto Rico, Dominican Republic) including provision of validation documents
  • Providing Computer System Validation training and Data Integrity Training (incl. template) to global project team
  • Advice and support to system owners to build and maintain GxP, Data Privacy and Integrity and IT Security conform systems
Fresenius Kabi (Bad Homburg, Germany)
1 Jahr 7 Monate
2014-11 - 2016-05

Monitoring, analyzing and communicating key reimbursement

Analyst, Health Policy & Reimbursement
Analyst, Health Policy & Reimbursement
  • Monitoring, analyzing and communicating key reimbursement and FDA regulation & current guidance documents relevant to Roche business
  • Engaged in and reported on various federal institutions, trade organizations ad hoc industry coalitions (e.g., AdvaMed, the American Medical Association, the Centers for Medicare and Medicaid Services) on behalf of Roche Diagnostics
  • Roll-Out of Customer Support Tool to identify coding & payment of Roche FDA-approved tests
  • Provision of Health Policy training to Sales & Marketing Teams
  • Design and implementation of web-based trainings regarding the Reimbursement environment of Tissue and Point-of-Care Diagnostics
  • Provision of internal and external customer support on Medicare & Medicaid issues for all Business Units
  • Development of extensive reimbursement guides for each Business Unit of the organization
Roche Diagnostics Corporation (Washington DC, USA)

Aus- und Weiterbildung

Aus- und Weiterbildung

2 Jahre 1 Monat
2018-02 - 2020-02

MBA, Business Management

MBA, Business Management, ESEI International Business School Barcelona (Barcelona, Spain
MBA, Business Management
ESEI International Business School Barcelona (Barcelona, Spain

Kompetenzen

Kompetenzen

Top-Skills

Data Integrity CSV Projekt Management (SCRUM & Traditionell) GAMP 5 SOP Creation, Review & Approval Data Integrity Strategy & Gap Assessment (ALCOA) Audit Preparation / Regulatory Compliance FDA 21 CFR Part 11, 211, 212, 820 MHRA, EMA, PDA, WHO, FDA Guidelines re: Data Integrity GxP (GCP , GDP , GMP , GLP) Electronic Records/ Electronic Signatures (21 CFR, Part 11)

Produkte / Standards / Erfahrungen / Methoden

OVERVIEW

  • Dynamic professional with agile-digital mindset with 10 years of global experience within the life science industry in various positions (Europe & United States)
  • Extensive experience in the IT Quality & Compliance Management field within the Pharmaceutical and Medical Device industry as consultant and employee for major life science companies (Roche Diagnostics, Fresenius, Boehringer Ingelheim, Johnson & Johnson, Merck, Henry Schein Group, BASF, Lonza, Novartis)
  • Computer System Validation, Data Integrity and Risk Management (FMEA)
  • GxP Compliance: audit / assessment preparation (for regulatory authorities and clients)
  • Global Project Management experience and leading of onshore and off-shore teams (Europe & United States)
  • Expertise in US Health Policy, Reimbursement and Market Access. Multiple years for Roche in Washington, DC
  • Global work experience in the United States and Europe enable me to excel in a multicultural environment. Working across cultures within the healthcare industry has provided me with keen insights and an understanding to communicate not only in different languages but also to understand different cultures and to act accordingly

PROFESSIONAL EXPERTISE

  • Computer System Validation (CSV) according to GAMP 5
  • Project Management (SCRUM & Traditional)
  • Global and local SOP Creation, Review & Approval
  • Data Integrity Strategy & Gap Assessment (ALCOA)
  • Audit Preparation / Regulatory Compliance within Pharmaceuticals and Medical Device industry
  • FDA 21 CFR Part 11, 211, 212, 820
  • MHRA, EMA, PDA, WHO, FDA Guidelines re: Data Integrity
  • GxP (GCP, GDP, GMP, GLP)
  • Electronic Records/ Electronic Signatures (21 CFR, Part 11)

EMPLOYERS & CLIENTS AS CONSULTANT

Employers:

  • Roche Diagnostics Corporation, United States
  • Roche Diagnostics, Germany
  • KVALITO Consulting Group
  • Digital Chameleon Consulting Group

Clients:

  • Fresenius Kabi, Germany
  • Fresenius Hemo Care Italia
  • Boehringer-Ingelheim, Germany
  • BASF Personal Care and Nutrition GmbH
  • Sutter Medizintechnik, Freiburg/DE
  • Fresenius Kabi Swiss BioSim, Eysin/CH
  • Altatec GmbH, Basel/CH, Wimsheim/DE
  • Merck Healthcare KGaA
  • Lonza, Switzerland
  • Novartis, Switzerland

COMPETENCIES

Regulations

  • FDA CFR Part 11, 211, 212, 820
  • EU GMP ? Annex 11
  • ISO 13485, ISO 14971, ISO 27001, ISO 9001
  • MHRA, EMA, PDA, WHO, FDA Guidelines re: Data Integrity
  • GxP (GCP, GDP, GMP, GLP)
  • Medicare & Medicaid (Centers for Medicare & Medicaid Services) regulations

Business Software, Hardware, Firmware

  • 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), Quality Master Data
  • SAP Hana Cloud (Application for Digital Home & Healthcare)
  • MES Manufacturing Execution Systems (PAS-X, PMX), Werum solutions
  • Test Management - HP Quality Center/ PROTON Test Software, SAP Solution Manager (Implementation, Test Workbench)
  • BPM Business Process Modelling ? ARIS, MS Visio (Data Flow Modelling)
  • CMS Content Management ?Microsoft Office SharePoint Server (ECM), Wordpress, HTML
  • Document Management - Documentum D2 and Life Science Suite, Veeva, Microsoft SharePoint
  • CRM Customer Relationship Management ? salesforce, Microsoft Dynamics

Vertrauen Sie auf GULP

Im Bereich Freelancing
Im Bereich Arbeitnehmerüberlassung / Personalvermittlung

Fragen?

Rufen Sie uns an +49 89 500316-300 oder schreiben Sie uns:

Das GULP Freelancer-Portal

Direktester geht's nicht! Ganz einfach Freelancer finden und direkt Kontakt aufnehmen.