GMP Operations Compliance Leader

UCB; Eigenbrakel; Hybride; EUR 110 000 - 150 000; Plein temps

Avantages offerts par ce poste

Hybrid work model

Résumé du poste

UCB is seeking a GMP Process and Operations Compliance Lead to join the Clinical Manufacturing team in Belgium. You will drive high-quality manufacturing operations while ensuring regulatory compliance across Chemical, Biological and GT pilot plants, working with QA and sustainability stakeholders.

You will lead a team, oversee deviation investigations, risk management, and continuous improvement, and collaborate with pilot plants, quality partners, and leadership to strengthen the quality

Qualifications

• Bachelor’s or Master’s degree in a scientific discipline required.
• Minimum 10 years in biopharmaceutical manufacturing or equivalent.
• Strong knowledge of regulations for low bioburden and sterile manufacturing.
• Experience with Deviations/Investigations, root cause analysis, and change management.

Responsabilités

• Lead quality and regulatory compliance across clinical manufacturing processes across pilot plants.
• Coach teams to embed a robust quality mindset and oversee deviation management and change controls.
• Coordinate audits, inspections, and compliance visits.

Connaissances

Leadership

Quality governance

Root cause analysis

Agile environment

French & English

Formation

Bachelor’s or Master’s in science

Description du poste

UCB is seeking a GMP Process and Operations Compliance Lead to join the Clinical Manufacturing team in Belgium. You will drive high-quality manufacturing operations while ensuring regulatory compliance across Chemical, Biological and GT pilot plants, working with QA and sustainability stakeholders.

You will lead a team, oversee deviation investigations, risk management, and continuous improvement, and collaborate with pilot plants, quality partners, and leadership to strengthen the quality