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
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Compliance Support: Ensuring adherence to GMP/GDP regulations, health and safety guidelines.
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Data Integrity Management: Active participation in QA forums and lead meetings to manage Data Integrity (DI).
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Documentation Systems: Supporting and maintaining compliant documentation processes for UCB development activities.
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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.
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Training: Providing GMP/GDP expertise and data integrity training to customer department members.
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QA Dev Compliance Oversight: Ensuring QMS compliance with regulations and policies, coordinating daily QA systems and DI activities.
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Data Integrity Governance: Leading CMC and CSC data integrity alignment, reviewing risk assessments, remediation plans, and effectiveness checks.
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Audit Management: Coordinating audit preparedness, managing responses to audit observations including CAPA activities.
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Continuous Improvement: Driving improvement opportunities related to QMS, Data Integrity, and Documentation Control; supporting digitalization initiatives.
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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.
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Backup Function: Serving as backup for the Dev Quality Lab Ops Partner to ensure continuity in QA Lab Oversight.
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Guidance and Issue Resolution: Providing expert advice on GMP regulations, identifying and resolving compliance and quality issues to support training and improvements.
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Support for Development Quality Lead: Assisting with laboratory/manufacturing quality systems activities such as deviation closeout, change management, complaints, and quality improvement.
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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
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Bachelor’s, master’s degree or an education in a relevant scientific discipline
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At least 5 years’ experience in a QA regulated pharmaceutical environment
- Fluent in French and English communication (oral and written); any additional languages are a plus.
- Strong knowledge of regulatory requirements (FDA, EudraLex, PIC/S, ICH)
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Experience in audit and inspection support
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Exhibit effective communication skills when interacting with stakeholders
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Capable of working independently and taking initiative
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Must be able to act in most circumstances without direct supervision and handle complex/urgent situations.
- 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!
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 [email protected]. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
