Make your mark for patients
To strengthen our Clinical Manufacturing Quality department we are looking for a talented profile to fill the position of: Development Quality Operations Data Integrity Partner – Braine l’Alleud, Belgium.
About the role
As part of Clinical Manufacturing Quality, you act as a Dev Quality Lab Ops Data Integrity Partner supporting CMC Development Sciences and Clinical Supply Chain entities. Your primary responsibility is to ensure the establishment, implementation, maintenance and continuous improvement of an effective Quality Management System (QMS) and robust Data Integrity practices across product development, from early clinical phases through to commercialization. This includes providing GMP oversight of laboratories at the Braine site in Belgium and GxP oversight of development entities across the Braine-l’Alleud and UK (e.g. Slough) campuses.
You will work with
In this role, you closely support the Labs & Dev Compliance Quality Lead by contributing to global quality oversight of clinical manufacturing and supply activities, working in close collaboration with both internal (Braine, Slough, Leuven) and external stakeholders.
What you will do
1. Compliance Support: Ensuring adherence to GMP/GDP regulations, health and safety guidelines.
2. Data Integrity Management: Active participation in QA forums and lead meetings to manage Data Integrity (DI).
3. Documentation Systems: Supporting and maintaining compliant documentation processes for UCB development activities.
4. Issued Copy Process: Acting as Reconciler to verify correct completion of the “issued copy” process and coordinating local instructions with stakeholders to maintain common practices.
5. Training: Providing GMP/GDP expertise and data integrity training to customer department members.
6. QA Dev Compliance Oversight: Ensuring QMS compliance with regulations and policies, coordinating daily QA systems and DI activities.
7. Data Integrity Governance: Leading CMC and CSC data integrity alignment, reviewing risk assessments, remediation plans, and effectiveness checks.
8. Audit Management: Coordinating audit preparedness, managing responses to audit observations including CAPA activities.
9. Continuous Improvement: Driving improvement opportunities related to QMS, Data Integrity, and Documentation Control; supporting digitalization initiatives.
10. Stakeholder Interface: Acting as the operational link between QA-Systems, CMC Development, Clinical Supply Chain, IT, and QA-Management; preparing compliance, KPI, and risk summaries.
11. Backup Function: Serving as backup for the Dev Quality Lab Ops Partner to ensure continuity in QA Lab Oversight.
12. Guidance and Issue Resolution: Providing expert advice on GMP regulations, identifying and resolving compliance and quality issues to support training and improvements.
13. Support for Development Quality Lead: Assisting with laboratory/manufacturing quality systems activities such as deviation closeout, change management, complaints, and quality improvement.
14. Coaching and Training: Delivering regular data integrity training and coaching across CMC Development and CSC entities
Interested? For this position you’ll need the following education, experience and skills
15. Bachelor’s, master’s degree or an education in a relevant scientific discipline
16. At least 5 years’ experience in a QA regulated pharmaceutical environment
17. Fluent in French and English communication (oral and written); any additional languages are a plus.
18. Strong knowledge of regulatory requirements (FDA, EudraLex, PIC/S, ICH)
19. Experience in audit and inspection support
20. Exhibit effective communication skills when interacting with stakeholders
21. Capable of working independently and taking initiative
22. Must be able to act in most circumstances without direct supervision and handle complex/urgent situations.
23. Analytical and problem-solving capabilities
Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!