GMP Process and Operations Compliance Lead
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 plants.
* Act as a leader and coach, supporting teams in strengthening a consistent quality mindset and embedding best practices in daily operations. Oversee deviation management, ensuring robust timely investigation processes, suitable action plans, and appropriate change controls.
* Lead the resolution of complex quality issues.
* Proactively identify, assess, and manage quality risks related to manufacturing process and operations.
* Define, 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 facilities.
* Lead 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.
Requirements
* Bachelor’s or Master’s degree in a scientific discipline.
* Extensive experience in biopharmaceutical manufacturing.
* Strong knowledge of regulations related to low bioburden and sterile manufacturing activities.
* Strong knowledge of quality systems and production systems including documentation and training management.
* Strong experience with deviations/investigations, root cause analysis, and change management.
* Experience in managing quality governance and KPIs.
* Decision maker, problem‑solving skills in a very agile environment.
* Proven ability to lead, coach, and develop a team.
* Strong communication skills in French and English, written and spoken.
Equal Opportunity Statement
UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws.
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