Head of Quality Operations & Interim Responsible Pharmacist

About the role

The Head of Quality Operations & Interim Responsible Pharmacist leads all pharmaceutical quality activities at the site, ensuring compliance with EU and UK regulations while supporting the company’s life‑science supply‑chain services. The role combines strategic oversight of quality assurance with hands‑on management of batch release, audits and regulatory dossiers, and includes occasional travel across France, the EU and the US.

Key responsibilities

• Ensure all pharmaceutical operations comply with applicable regulations (GMP, EU, UK).
• Organise, support and manage the company’s pharmaceutical activities, including importation of ATMP and clinical batches.
• Oversee EU certification, batch release, and quality control of pharmaceutical products.
• Lead audits, inspections and client visits at subcontractor and supplier sites.
• Maintain qualified status of premises, equipment, suppliers and personnel.
• Review and certify batch records, master batch records and release documentation.
• Manage deviations, CAPAs, change controls and continuous improvement initiatives.
• Prepare regulatory dossiers and support site projects, including integration of Veeva and MyCellHub systems.

Required profile

• Extensive experience in pharmaceutical quality assurance and operations management.
• Strong knowledge of EU, UK and US GMP regulations.
• Proven ability to lead QA teams and coordinate multi‑site audits.
• Experience with batch record review, certification and release processes.
• Excellent communication skills for interaction with clients, regulators and internal stakeholders.

Required skills

• Veeva
• MyCellHub