Head of Commissioning and Qualification

About the role

The Head of Commissioning and Qualification leads the strategy, planning and execution of commissioning, qualification and validation activities across projects and operational facilities, ensuring compliance with regulatory and quality standards.

Key responsibilities

• Develop and implement site‑wide C&Q strategy aligned with business objectives and regulatory requirements.
• Oversee commissioning and qualification of manufacturing equipment, single‑use bioreactors, upstream/downstream systems, fill‑finish, clean utilities, HVAC, cleanrooms and automation.
• Lead C&Q activities for large‑scale capital projects, manage external contractors and provide governance and reporting to senior leadership.
• Ensure compliance with EU GMP Annex 15, FDA 21 CFR Parts 210/211/11, ISPE Baseline Guides, ASTM E2500 and GAMP 5, and support regulatory inspections.
• Build, mentor and develop a high‑performing C&Q team, driving continuous improvement and succession planning.

Required profile

• University degree in engineering, natural sciences or related field.
• 10+ years of experience in the pharmaceutical industry with proven people‑leadership experience.
• Expertise in qualification of equipment for aseptic and biological processes.
• Strong communication, analytical and stakeholder‑management skills.

Required skills

• Commissioning and qualification of GMP equipment and systems.
• Validation lifecycle management (DQ, IQ, OQ, PQ).
• Regulatory standards: EU GMP Annex 15, FDA 21 CFR Parts 210/211/11, ISPE, ASTM E2500, GAMP 5.
• Risk‑based approach and CAPA management.