Manager - IT Quality and Computerized Systems Validation

The Manager, IT Quality and Computerized Systems Validation, reporting to the Senior Manager, BI&T Quality & Compliance for the Leiden Cell Therapy Facility (CTF), will provide subject matter expertise and lead the Computer System Validation (CSV) and IT Compliance function for the Leiden CTF. Key responsibilities include managing CSV activities, supporting deviations and change controls, acting as CSV SME, managing the CSV program, reviewing and approving qualification documents, participating in regulatory audits, and ensuring SOPs are updated.

Must Have

• Manage computerized system validation (CSV) activities and major projects
• Support deviations and change controls related to computerized systems
• Act as CSV Subject Matter Expert (SME)
• Manage CSV program, ensuring standardization and consistency
• Review and approve qualification documents
• Participate in regulatory audits as Digital Plant representative
• Provide IT quality support to Leiden CTF Digital Plant team
• Interact with Infinity (Change Management system) for deviations, investigations, CAPA
• Perform project audits
• Ensure Digital Plant SOPs and procedural methodologies are reviewed and updated
• Assist in development of appropriate validation methodologies
• Provide CSV input to multi-function teams
• Bachelor’s in engineering, IT, Science field or equivalent
• Minimum 5+ years relevant industry experience
• Demonstrated experience with IT Quality & Compliance applications and systems in a bio-tech manufacturing environment
• Understanding of supply chain, manufacturing, and quality domains and supporting technology (MES, LIMS, QMS, ERP, Process Automation, Historians)
• Working knowledge of GxP regulatory requirements
• Knowledge of industry standard Quality and Compliance methodology
• Knowledge of cGMP, GXP, GAMP, SDLC regulations, 21CFR part 11, EudraLex Annex 11, and good documentation practices

Perks & Benefits

• Challenging, meaningful, life-changing work
• Opportunities to grow and thrive
• Competitive benefits, services, and programs
• Balance and flexibility in work environment
• Inclusive culture
• Empowerment to leverage individual talents and diverse perspectives
• Shared values: passion, innovation, urgency, accountability, inclusion, integrity
• Benefits and Wellbeing (Global platform and benefits for physical, mental, financial and social wellbeing)
• Recognition (Global platform to reward your achievements)
• Time Off (Generous time off to rest and recharge)
• Health Benefits (Best-in-class benefits)
• 8 People & Business Resource Groups

Position Summary

Reporting into the Senior Manager, BI&T Quality & Compliance for the Leiden Cell Therapy Facility (CTF), the Manager, IT Quality and Computerized Systems Validation will provide subject matter expertise and lead the Computer System Validation (CSV) and IT Compliance function for the Leiden Cell Therapy Facility on an ongoing basis.

Key Responsibilities

• The Manager, IT Quality and Compliance, role will provide support through managing the computerized system validation (CSV) activities / major projects and supporting deviations and change controls related to computerized systems.
• Demonstrated working knowledge of the principles theories and concepts of computerized systems validation/compliance (GAMP5)
• Act as CSV Subject Matter Expert (SME) for computerized system related changes and associated IT/Automation projects – advising operations on CSV matters and defending their work before regulatory agencies.
• Manages CSV program, ensuring standardization and consistency of qualification testing documents and associated testing deviations.
• Review and approve qualification documents as part of CSV activities, supporting the pre- and post-approval of qualification testing.
• Participates in regulatory audits as Digital Plant representative and assists in generating responses to audit observations.
• Provides IT quality support to Leiden CTF Digital Plant team through quality review and approval of investigations or change controls, deviation ownership of computerized system events, and CSV activities.
• Interact with Infinity (Change Management system) to enter deviations and associated actions, investigations, and associated root cause analyses, supporting data, corrective action/preventative action (CAPA), and effectiveness reviews as needed.
• Perform project audits as the needs arise.
• Ensure that Digital Plant standard operating procedures (SOPs) and procedural methodologies employed to maintain the validated state are regularly reviewed and updated, as needed.
• Assist in development of appropriate validation methodologies in collaboration with Operations
• Provide CSV input to multi-function teams, advises operations on CSV matters, and defend their work before regulatory agencies.
• Duties may include internal compliance or efficiency improvement efforts within department.

Qualifications & Experience

• Bachelor’s in engineering, IT, Science field or equivalent
• Minimum 5+ year’s relevant industry experience. Prior Cell Therapy experience is highly valued but not required.
• Demonstrated experience with IT Quality & Compliance applications and systems in a bio-tech manufacturing environment.
• Understanding of, and experience with, supply chain, manufacturing and quality domains and supporting technology including Manufacturing systems (MES), Quality systems (LIMS, QMS), Supply chain systems (ERP), Process Automation and Historians.
• Working knowledge of regulatory requirements and how they relate to existing and new business systems and practices, primarily GxP.
• Knowledge of industry standard Quality and Compliance methodology to ensure our IT systems deliver the intended performance and ensure they meet regulatory requirements.
• Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, EudraLex Annex 11 and good documentation practices.
• Demonstrated success working in a high-performing, business results-driven environment.