GMP Process and Operations Compliance Lead
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Make your mark for patients
We are looking for a GMP Process and Operations Compliance Lead who is collaborative, quality‑driven, and proactive to join our Clinical Manufacturing team (Pharma and Biologicals, mAb and Gene Therapy), based in Braine‑l’Alleud, Belgium.
About the role
You will play a key role in ensuring high standards of quality and regulatory compliance across clinical manufacturing operations. You will support safe, compliant manufacturing processes while driving continuous improvement Working in a complex, regulated environment, you will help teams deliver high‑quality products that support patient needs worldwide.
Who you’ll work with
You will be working in a multidisciplinary team that brings together manufacturing, engineering, supply, and quality professionals. You will collaborate closely with pilot plant teams, quality partners, and leadership to maintain compliance, share best practices, manage risks and foster a strong quality culture.
What you’ll do
Lead quality and regulatory compliance across clinical manufacturing processes and operations, working transversally across Chemical, Biological and GT pilot plantsAct as a leader and coach, supporting teams in strengthening a consistent quality mindset and embedding best practices in daily operations.Overseedeviation management, ensuring robust timely investigation processes, suitable actions plans, and appropriate change controls.
Lead the resolution of complex quality issues Proactively identify, assess, and manage quality risks related to manufacturing process and operationsDefine, Monitor and analyze quality performance indicators, driving continuous improvement initiatives across clinical manufacturing activities.
Ensure effective quality Governance, including the organization and leadership of Quality Councils in close collaboration with QA and stakeholders.
Coordinate audits, inspections, and compliance visits across pilot plant facilitiesLead and develop a team of compliance professionals, fostering engagement, accountability, and professional growth.
Act as a key contributor to the evolution of UCB standards, reviewing them constructively and fostering transversal alignment to strengthen compliance.
Interested?
For this role we’re looking for the following education, experience and skills
Bachelor’s or Master’s degree in a scientific disciplineAt least 10 years of experience in biopharmaceutical manufacturingStrong knowledge of regulations related to low bioburden and sterile manufacturing activitiesStrong knowledge of quality systems and production systems including documentation, and training managementStrong Experience with Deviations/Investigations, root cause analysis, and change managementExperience in managing Quality Governance and KPIsDecision maker, Problem solving skills in a very agile environmentProven ability to lead, coach, and develop a teamStrong communication skills in French and English, written and spokenAre 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
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