Make your mark for patients
To strengthen our External and Clinical Supply Quality department, we are looking for a talented profile to fill the position of: Head of Quality Gene Therapy Manufacturing Operations
– Braine l’Alleud, Belgium.
About the role
The role relates to UCB new Gene Therapy facility (Genesis project - building T4) on the Braine l’Alleud campus. You will lead through the project phase and then oversee Drug Substance and Drug Product operations within the Gene Therapy Pilot Plant, including managing the Internal Operations Quality Team and providing on‑call support when needed. You will drive continuous quality improvement by maintaining a robust Quality Management System and ensuring CMC Development activities meet regulatory expectations for product quality, safety and efficacy, while ensuring full compliance and supporting overall business performance.
You will work with
In this role, you will work closely with teams across the Gene Therapy Pilot Plant, collaborating daily with Drug Substance and Drug Product manufacturing teams, CMC Development, Quality Control and technical functions involved in process and clinical supply activities. You will also partner with your Internal Operations Quality Team, interact with facility operations, logistics, laboratory groups and engage with senior stakeholders and regulatory affairs to ensure alignment on quality expectations and readiness for inspections.
What you will do
1. Ensuring the manufacture of DS and DP materials for clinical trials in compliance with Good Manufacturing Practices (Directive 2003/94/EC), Article 13.3 and Article 9.2 of Directive 2001/20/EC, and relevant Product Specification Files.
2. Acting as a Qualified Person (QP) for the certification and release of clinical trial materials, demonstrating compliance with all applicable regulatory requirements.
3. Leading the Internal Operations Quality Team supporting manufacturing activities at the Gene Therapy Pilot Plant.
4. Overseeing QA development projects for CMC process development and clinical supply, including manufacturing oversight, batch record review, and product release from early phase to commercial launch.
5. Ensuring robust documentation systems and processes for CMC development projects, including SOP and protocol review and approval.
6. Managing specification review and release of materials used in DS and DP production for clinical trials.
7. Supporting CMC and Development QA activities, including deviation closure, change management, complaints, and quality improvement initiatives.
8. Ensuring ongoing compliance with all relevant regulations (EMEA, FDA, MHRA, etc.), and achieving successful outcomes in audits and inspections, particularly those by government agencies.
9. Driving local quality and operational excellence improvements by identifying, developing, and implementing innovative solutions in response to business, technical, and regulatory changes.
10. Reviewing and providing QP approval for major and critical deviations, change controls, and complaints.
Interested? For this position you’ll need the following education, experience and skills
11. Bachelor’s/master’s degree or an education in a relevant scientific discipline
12. Fluent English and French communication (oral and written); any additional languages are a plus
13. Belgium formally recognised QP certification is a great asset
14. Extensive experience in pharmaceutical regulated environments, including ATMP manufacturing and related quality requirements
15. Proven leadership in people management and team development
16. Deep expertise in sterile parenteral, gene therapy, biologics products etc.
17. Thorough understanding and interpretation of current regulatory requirements (cGMP, EMEA, FDA, MHRA, US, European, Japanese).
18. Experience managing regulatory inspections (including PAI) and ensuring compliance across manufacturing, facility operations, logistics, laboratory, and quality systems.
19. Skilled in compliance, quality assurance/control, validation, technical services and at least one scientific discipline related to pharmaceutical sciences
20. Familiarity with SAP is an asset.
21. Demonstrates autonomy and effectiveness in complex situations, influencing senior stakeholders and driving results across departments
22. Proven ability to lead and motivate teams globally, set challenging objectives, and foster commitment and innovation.
23. Excellent interpersonal, verbal, and written communication skills at all organizational levels.
24. Develops innovative solutions using sound judgment and extensive quality experience.
25. Experienced in failure investigations and root cause analysis; coaches others to resolve problems creatively and effectively.
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!