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
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
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.
Acting as a Qualified Person (QP) for the certification and release of clinical trial materials, demonstrating compliance with all applicable regulatory requirements.
Leading the Internal Operations Quality Team supporting manufacturing activities at the Gene Therapy Pilot Plant.
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.
Ensuring robust documentation systems and processes for CMC development projects, including SOP and protocol review and approval.
Managing specification review and release of materials used in DS and DP production for clinical trials.
Supporting CMC and Development QA activities, including deviation closure, change management, complaints, and quality improvement initiatives.
Ensuring ongoing compliance with all relevant regulations (EMEA, FDA, MHRA, etc.), and achieving successful outcomes in audits and inspections, particularly those by government agencies.
Driving local quality and operational excellence improvements by identifying, developing, and implementing innovative solutions in response to business, technical, and regulatory changes.
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
Bachelor’s/master’s degree or an education in a relevant scientific discipline
Fluent English and French communication (oral and written); any additional languages are a plus
Belgium formally recognised QP certification is a great asset
Extensive experience in pharmaceutical regulated environments, including ATMP manufacturing and related quality requirements
Proven leadership in people management and team development
Deep expertise in sterile parenteral, gene therapy, biologics products [SL3] etc.
Thorough understanding and interpretation of current regulatory requirements (cGMP, EMEA, FDA, MHRA, US, European, Japanese).
Experience managing regulatory inspections (including PAI) and ensuring compliance across manufacturing, facility operations, logistics, laboratory, and quality systems.
Skilled in compliance, quality assurance/control, validation, technical services and at least one scientific discipline related to pharmaceutical sciences
Familiarity with SAP is an asset.
Demonstrates autonomy and effectiveness in complex situations, influencing senior stakeholders and driving results across departments
Proven ability to lead and motivate teams globally, set challenging objectives, and foster commitment and innovation.
Excellent interpersonal, verbal, and written communication skills at all organizational levels.
Develops innovative solutions using sound judgment and extensive quality experience.
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!
About Us
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are over 9.000 people in all four corners of the globe, inspired by patients and driven by science.
Why work with us?
At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equal opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.
At UCB, we’ve embraced a hybrid-first approach to work, bringing teams together in local hubs to foster collaborative curiosity. Unless expressly stated in the description or precluded by the nature of the position, roles are hybrid with 40% of your time spent in the office.
UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on EMEA-Reasonable_Accommodation@ucb.com. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
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