QA Senior Manager / Digital Enablement Lead / IT Compliance Expert
Aktualisiert am 10.01.2025
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 10.01.2025
Verfügbar zu: 100%
davon vor Ort: 100%
Data Integrity
Digitalisierung
Qualitymanagement
agiles Projektmanagement
Good Manufacturing Practice
GxP
Auditor
Computerized System Validation
German
native speaker (C2)
English
business fluent (C1)
Spanish
beginner (A2)
French
beginner (A2)

Einsatzorte

Einsatzorte

Ühlingen-Birkendorf (+100km)
Deutschland, Schweiz
möglich

Projekte

Projekte

1 year 9 months
2023-04 - now

AI-powered solution for managing deviations

Digital Enablement Lead
Digital Enablement Lead

Pilot an AI-powered solution for managing deviations at one site, with the intention of scaling the solution acrosss subsidiaries. Proof of Concept aims to demonstrate the feasibility of using GenAI for deviations management. 

  • Project Lead within the AI Accelator Program
  • Aligning quality standards and compliance requirements, ensuring the AI solution meets the necessary governance and oversight
  • Ensurance of Data Privacy Compliance

Global australian biotechnological company (30.000 employees)
8 months
2024-01 - 2024-08

Global Data Integrity Program

Data Integrity Business Process Owner
Data Integrity Business Process Owner

  • Stream A: Governance: Enhance governance processes globally and at the site level to close gaps, monitor progress, and assses ongoing risk.
  • Stream B: Procedures: Implementation of an enhanced CSV strategy for I&T Enterprise Systems, Manufacturing Execution Systems, and Laboratory Execution Systems. It includes the cataloging of global procedures and CSV templates for QMS enhancement.
  • Stream C: CAPA Plan for Existing Systems: Compliance checks of data systems using a standard and uniform methodology to create a CAPA plan for existing systems.
  • Stream D: Remediation: Based on the output of Stream C, remediation is based on high-risk systems and plan takes timing, ressources into consideration.
  • Stream E1 & E2: Data Audit Trail Review/ System Periodic Review Support for site Manufacturing and Quality Control for site GxP data system inventory lists and the full implementation of global DATR & SPR procedures against these systems.


Other

  • Owner of Stream A ? E1&E2
  • Accountable for the achievement of objectives and main contact to Steering Committee.
  • Data Integrity Responsible during authority inspections (participated in SwissMedic, TMMDA, PMDA, FDA)

Global australian biotechnological company (30.000 employees)
1 year 3 months
2022-11 - 2024-01

Digital Manufacturing Foundation

Quality Assurance Manager
Quality Assurance Manager

Establish a compliant IT infrastructure tailored for a manufacturing & quality control facility. Key projects include implementing network monitoring and alert system, transitioning to a new EBR system, and fostering the integration of an advanced MES. 

  • Developing and instituting a comprehensive qualification strategy

Global australian biotechnological company (30.000 employees)
1 year 7 months
2019-03 - 2020-09

Global cloud solution for managing and signing electronic documents

Validation Lead
Validation Lead

Evaluating IT security aspects (multi-factor authentication, ISO 27001, HIPAA, Sarbanes Oxley, Service Organisation Control). Creating global work instructions for electronic records (e-archiving). Focus is on the validation activities in the ongoing cloud based global microsoft based enterprise content system.

  • Validation Planning
  • Realising cloud validation activities
  • Cloud vendor assessment
  • Creating and reviewing documents
  • Creating and supervising a Data Integrity concept
  • IT Security

Swiss pharmaceutical company (300 employees, 5 locations)
6 months
2020-02 - 2020-07

Implementation of the Enhancement Package 8 for SAP ERP 6.0

Validation Lead
Validation Lead

Implementing SAP Inhouse as an on-premise solution. Upgrading SAP after transfer from an external host. Including software testing managed and supervised by the validation expert.

  • Supporting Business Stakeholders to describe and update the relevant processes
  • Supporting writing and review testcases
  • Interviewing SMEs and SAP users
  • Planning and coordinating testing activities
  • Providing hands-on support for testing activities
  • Documenting UAT

Swiss pharmaceutical company (2000 employees, 3 locations)
2 years
2018-08 - 2020-07

Instrumentation/Equipment Qualification for a Product Pipeline

Engineer Qualification Expert
Engineer Qualification Expert

Creating and reviewing required documentation (plans, protocols, risk analysis, reports). Processing customer-specific inquiries regarding qualification.

  • Performing qualification and risk assessment for qualification reports
  • Achieving ISO 13485 and GMP compliance

International German Biopharmaceutical Company (400 employees, 3 locations)
9 months
2019-06 - 2020-02

QSIS system validation according to GMP requirements

CSV Consultant
CSV Consultant

Validating a Quality Assurance Information System (QSIS). Creating a comprehensive analysis of requirements, risk analysis and test documents. Planning and leading the user acceptance testing.

  • Acting as a support CSV lead with execution of validation activities
  • Creating validation documentations

Global German chemical company (120,000 employees, global locations)
1 year
2019-03 - 2020-02

Facility Management Support

Project Lead
Project Lead

Maintaining cleanrooms according to ISO 14644. Project management of facility management for three production lines. Supervising activities relating to cleanrooms and procedures for safeguarding maintenance, safety and security.

  • Leading a team of three (3)
  • Managing the project during production shut-down phase
  • Consulting in regulations concerning cleanrooms

German Biopharmaceutical company (400 employees, 3 locations)
1 year 2 months
2018-12 - 2020-01

Due Diligence Examination

Junior Consultant
Junior Consultant

Collecting information in order to provide a deeper understanding of customer activity to mitigate risks.

  • Collecting, processing and analysing data
  • Assess risk and compliance of contracts

US Biopharmaceutical company (7300 employees, global locations)

Aus- und Weiterbildung

Aus- und Weiterbildung

5 years 11 months
2012-10 - 2018-08

M.Sc. Biochemistry

Univsersity of Tübingen
Univsersity of Tübingen
  • Master thesis & project in SaliPro Biotech AB (Sweden)
  • Research in Paul-Scherrer Institute (PSI) and Deutsches Elektronen Synchrotron (DESY)

Kompetenzen

Kompetenzen

Top-Skills

Data Integrity Digitalisierung Qualitymanagement agiles Projektmanagement Good Manufacturing Practice GxP Auditor Computerized System Validation

Produkte / Standards / Erfahrungen / Methoden

EXECUTIVE SUMMARY

A highly skilled professional with extensive experience in quality systems, data integrity, and digital transformation in the pharmaceutical and biotech industries. Demonstrated expertise in leading strategic digital enablement projects, ensuring compliance with global standards, and leveraging advanced technologies like AI and ML for process improvement. Proven track record in managing cross-functional teams, overseeing large-scale quality management systems, and driving innovation through data analytics.


PROFESSIONAL SKILLS

  • Data Integrity
  • Digital Transformation
  • AI/ML
  • Compliance
  • Project Management
  • CSV
  • Lead Auditor
  • ISO 9001
  • GAMP 5
  • SAP ERP
  • Data Analytics
  • OCM
  • Quality Assurance
  • IT Infrastructure Validation
  • GMP
  • GxP
  • Facility Management
  • UAT
  • Cloud Solutions
  • IT Security
  • ISO 27001
  • Service Organization Control (SOC)
  • Cleanroom Management
  • Vendor Assessment
  • Quality Control
  • Data Governance


PROFESSIONAL EXPERIENCE

07/2024 ? 11/2024

Rolle: Global Quality System & Compliance Digital Enablement Lead

Kunde: CSL, Global


Aufgaben:

  • The role involves developing and implementing a strategic vision for digital transformation in quality systems, integrating advanced technologies like AI and ML to enhance processes and ensure alignment with business goals. It includes leading cross-functional projects and promoting continuous improvement.
  • I am accountable for achieving digital transformation objectives, maintaining compliance standards, and effectively managing resources.
  • Additionally, overseeing change management and regularly reporting on the performance of digital initiatives are key responsibilities.


01/2024 ? 06/2024

Rolle: Data Integrity Business Process Owner (Senior Manager)

Kunde: CSL, Global


Aufgaben:

  • Championed the enhancement of the Global DI Framework, collaborating with local DI site leads.
  • Steering DI-related training and campaigns, key member of the Data Governance Council.
  • Provided support to the DI Program, DI assessments, remediation activities, and during inspections. 


11/2022 ? 01/2024

Rolle: CSV Compliance & PM GenAI (Manager)

Kunde: CSL Vifor, Switzerland


Aufgaben:

  • QA & Project lead for data integrity at the Zurich & St. Gallen site. Responsible for the validation of the IT infrastructure and various computer-based systems.
  • Certified lead auditor (internal & external), qualified for ISO 9001 audits.
  • WorkSmart Champion: Gold Medal 2023, Co-Pilot key user 2023, LLM based audit report.
  • CSL GenAI Accelerator Program: Project Manager for Use Case ?Predictive Forecasting?, securing budget approval from the Leadership Steering Committee.
  • Innovated within the QM System Compliance Group by integrating Data Analytics and showcased results during the Business Review Meeting to leadership.


04/2023 ? ongoing

Rolle: Managing Partner

Kunde: Runom GmbH, DACH Region


Aufgaben:

  • Accountable for setting the strategic direction of the firm, including identifying new business opportunities.
  • Responsible for overseeing the financial health of the firm, including budgeting, financial planning, and ensuring profitability.
  • Managing Consultant for ISO certified medium-sized companies.
  • SME for deep learning, machine learing and natural language processing/ large language models.


07/2020 ? 11/2022

Rolle: Quality Assurance Manager

Kunde: Zeria Group ? Tillotts Pharma locations in Switzerland


Aufgaben:

  • QA lead for data integrity and CSV for 2 sites and 6 subsidiaries.
  • QA business owner of batch release/SC (ERP), deviations, training and documentation.
  • Process owner for the implementation of a global quality management software. Project management of team (6) and management of key user (16). 


08/2018 ? 07/2020

Rolle: IT Compliance Consultant (Supervisor/Individual Contributor)

Kunde: Arcondis AG, DACH Region


Aufgaben:

  • Validation/ Qualification lead for IT systems, equipment and facilities (e.g. SCADA, MES, biotech production facility).
  • Lead for 2 junior consultants at 2 client projects. Certified lead auditor (internal & external), qualified for ISO 9001 audits.
  • Highest utilization average within the team.

Einsatzorte

Einsatzorte

Ühlingen-Birkendorf (+100km)
Deutschland, Schweiz
möglich

Projekte

Projekte

1 year 9 months
2023-04 - now

AI-powered solution for managing deviations

Digital Enablement Lead
Digital Enablement Lead

Pilot an AI-powered solution for managing deviations at one site, with the intention of scaling the solution acrosss subsidiaries. Proof of Concept aims to demonstrate the feasibility of using GenAI for deviations management. 

  • Project Lead within the AI Accelator Program
  • Aligning quality standards and compliance requirements, ensuring the AI solution meets the necessary governance and oversight
  • Ensurance of Data Privacy Compliance

Global australian biotechnological company (30.000 employees)
8 months
2024-01 - 2024-08

Global Data Integrity Program

Data Integrity Business Process Owner
Data Integrity Business Process Owner

  • Stream A: Governance: Enhance governance processes globally and at the site level to close gaps, monitor progress, and assses ongoing risk.
  • Stream B: Procedures: Implementation of an enhanced CSV strategy for I&T Enterprise Systems, Manufacturing Execution Systems, and Laboratory Execution Systems. It includes the cataloging of global procedures and CSV templates for QMS enhancement.
  • Stream C: CAPA Plan for Existing Systems: Compliance checks of data systems using a standard and uniform methodology to create a CAPA plan for existing systems.
  • Stream D: Remediation: Based on the output of Stream C, remediation is based on high-risk systems and plan takes timing, ressources into consideration.
  • Stream E1 & E2: Data Audit Trail Review/ System Periodic Review Support for site Manufacturing and Quality Control for site GxP data system inventory lists and the full implementation of global DATR & SPR procedures against these systems.


Other

  • Owner of Stream A ? E1&E2
  • Accountable for the achievement of objectives and main contact to Steering Committee.
  • Data Integrity Responsible during authority inspections (participated in SwissMedic, TMMDA, PMDA, FDA)

Global australian biotechnological company (30.000 employees)
1 year 3 months
2022-11 - 2024-01

Digital Manufacturing Foundation

Quality Assurance Manager
Quality Assurance Manager

Establish a compliant IT infrastructure tailored for a manufacturing & quality control facility. Key projects include implementing network monitoring and alert system, transitioning to a new EBR system, and fostering the integration of an advanced MES. 

  • Developing and instituting a comprehensive qualification strategy

Global australian biotechnological company (30.000 employees)
1 year 7 months
2019-03 - 2020-09

Global cloud solution for managing and signing electronic documents

Validation Lead
Validation Lead

Evaluating IT security aspects (multi-factor authentication, ISO 27001, HIPAA, Sarbanes Oxley, Service Organisation Control). Creating global work instructions for electronic records (e-archiving). Focus is on the validation activities in the ongoing cloud based global microsoft based enterprise content system.

  • Validation Planning
  • Realising cloud validation activities
  • Cloud vendor assessment
  • Creating and reviewing documents
  • Creating and supervising a Data Integrity concept
  • IT Security

Swiss pharmaceutical company (300 employees, 5 locations)
6 months
2020-02 - 2020-07

Implementation of the Enhancement Package 8 for SAP ERP 6.0

Validation Lead
Validation Lead

Implementing SAP Inhouse as an on-premise solution. Upgrading SAP after transfer from an external host. Including software testing managed and supervised by the validation expert.

  • Supporting Business Stakeholders to describe and update the relevant processes
  • Supporting writing and review testcases
  • Interviewing SMEs and SAP users
  • Planning and coordinating testing activities
  • Providing hands-on support for testing activities
  • Documenting UAT

Swiss pharmaceutical company (2000 employees, 3 locations)
2 years
2018-08 - 2020-07

Instrumentation/Equipment Qualification for a Product Pipeline

Engineer Qualification Expert
Engineer Qualification Expert

Creating and reviewing required documentation (plans, protocols, risk analysis, reports). Processing customer-specific inquiries regarding qualification.

  • Performing qualification and risk assessment for qualification reports
  • Achieving ISO 13485 and GMP compliance

International German Biopharmaceutical Company (400 employees, 3 locations)
9 months
2019-06 - 2020-02

QSIS system validation according to GMP requirements

CSV Consultant
CSV Consultant

Validating a Quality Assurance Information System (QSIS). Creating a comprehensive analysis of requirements, risk analysis and test documents. Planning and leading the user acceptance testing.

  • Acting as a support CSV lead with execution of validation activities
  • Creating validation documentations

Global German chemical company (120,000 employees, global locations)
1 year
2019-03 - 2020-02

Facility Management Support

Project Lead
Project Lead

Maintaining cleanrooms according to ISO 14644. Project management of facility management for three production lines. Supervising activities relating to cleanrooms and procedures for safeguarding maintenance, safety and security.

  • Leading a team of three (3)
  • Managing the project during production shut-down phase
  • Consulting in regulations concerning cleanrooms

German Biopharmaceutical company (400 employees, 3 locations)
1 year 2 months
2018-12 - 2020-01

Due Diligence Examination

Junior Consultant
Junior Consultant

Collecting information in order to provide a deeper understanding of customer activity to mitigate risks.

  • Collecting, processing and analysing data
  • Assess risk and compliance of contracts

US Biopharmaceutical company (7300 employees, global locations)

Aus- und Weiterbildung

Aus- und Weiterbildung

5 years 11 months
2012-10 - 2018-08

M.Sc. Biochemistry

Univsersity of Tübingen
Univsersity of Tübingen
  • Master thesis & project in SaliPro Biotech AB (Sweden)
  • Research in Paul-Scherrer Institute (PSI) and Deutsches Elektronen Synchrotron (DESY)

Kompetenzen

Kompetenzen

Top-Skills

Data Integrity Digitalisierung Qualitymanagement agiles Projektmanagement Good Manufacturing Practice GxP Auditor Computerized System Validation

Produkte / Standards / Erfahrungen / Methoden

EXECUTIVE SUMMARY

A highly skilled professional with extensive experience in quality systems, data integrity, and digital transformation in the pharmaceutical and biotech industries. Demonstrated expertise in leading strategic digital enablement projects, ensuring compliance with global standards, and leveraging advanced technologies like AI and ML for process improvement. Proven track record in managing cross-functional teams, overseeing large-scale quality management systems, and driving innovation through data analytics.


PROFESSIONAL SKILLS

  • Data Integrity
  • Digital Transformation
  • AI/ML
  • Compliance
  • Project Management
  • CSV
  • Lead Auditor
  • ISO 9001
  • GAMP 5
  • SAP ERP
  • Data Analytics
  • OCM
  • Quality Assurance
  • IT Infrastructure Validation
  • GMP
  • GxP
  • Facility Management
  • UAT
  • Cloud Solutions
  • IT Security
  • ISO 27001
  • Service Organization Control (SOC)
  • Cleanroom Management
  • Vendor Assessment
  • Quality Control
  • Data Governance


PROFESSIONAL EXPERIENCE

07/2024 ? 11/2024

Rolle: Global Quality System & Compliance Digital Enablement Lead

Kunde: CSL, Global


Aufgaben:

  • The role involves developing and implementing a strategic vision for digital transformation in quality systems, integrating advanced technologies like AI and ML to enhance processes and ensure alignment with business goals. It includes leading cross-functional projects and promoting continuous improvement.
  • I am accountable for achieving digital transformation objectives, maintaining compliance standards, and effectively managing resources.
  • Additionally, overseeing change management and regularly reporting on the performance of digital initiatives are key responsibilities.


01/2024 ? 06/2024

Rolle: Data Integrity Business Process Owner (Senior Manager)

Kunde: CSL, Global


Aufgaben:

  • Championed the enhancement of the Global DI Framework, collaborating with local DI site leads.
  • Steering DI-related training and campaigns, key member of the Data Governance Council.
  • Provided support to the DI Program, DI assessments, remediation activities, and during inspections. 


11/2022 ? 01/2024

Rolle: CSV Compliance & PM GenAI (Manager)

Kunde: CSL Vifor, Switzerland


Aufgaben:

  • QA & Project lead for data integrity at the Zurich & St. Gallen site. Responsible for the validation of the IT infrastructure and various computer-based systems.
  • Certified lead auditor (internal & external), qualified for ISO 9001 audits.
  • WorkSmart Champion: Gold Medal 2023, Co-Pilot key user 2023, LLM based audit report.
  • CSL GenAI Accelerator Program: Project Manager for Use Case ?Predictive Forecasting?, securing budget approval from the Leadership Steering Committee.
  • Innovated within the QM System Compliance Group by integrating Data Analytics and showcased results during the Business Review Meeting to leadership.


04/2023 ? ongoing

Rolle: Managing Partner

Kunde: Runom GmbH, DACH Region


Aufgaben:

  • Accountable for setting the strategic direction of the firm, including identifying new business opportunities.
  • Responsible for overseeing the financial health of the firm, including budgeting, financial planning, and ensuring profitability.
  • Managing Consultant for ISO certified medium-sized companies.
  • SME for deep learning, machine learing and natural language processing/ large language models.


07/2020 ? 11/2022

Rolle: Quality Assurance Manager

Kunde: Zeria Group ? Tillotts Pharma locations in Switzerland


Aufgaben:

  • QA lead for data integrity and CSV for 2 sites and 6 subsidiaries.
  • QA business owner of batch release/SC (ERP), deviations, training and documentation.
  • Process owner for the implementation of a global quality management software. Project management of team (6) and management of key user (16). 


08/2018 ? 07/2020

Rolle: IT Compliance Consultant (Supervisor/Individual Contributor)

Kunde: Arcondis AG, DACH Region


Aufgaben:

  • Validation/ Qualification lead for IT systems, equipment and facilities (e.g. SCADA, MES, biotech production facility).
  • Lead for 2 junior consultants at 2 client projects. Certified lead auditor (internal & external), qualified for ISO 9001 audits.
  • Highest utilization average within the team.

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