Head of Quality Operations & Interim Responsible Pharmacist (Pharmacien Responsable Intérimaire)

Job Information

Job Type

Full-Time, Permanent

Posted on

17 August 2026

Experience

5+ years

Best Canditate

Role Overview

The Head of Quality Operations is responsible for organising, managing, and overseeing all pharmaceutical operations and associated functions at site level. There will be occasional travel to customer sites across France and the EU to undertake audits as well as occasional travel to our client sites in the US. Key Responsibilities: The postholder is accountable for:

Quality assurance related to all pharmaceutical activities within the organisation.
Ensuring all pharmaceutical operations comply with applicable regulations.
Organise, support, and manage the company’s pharmaceutical activities.
Importation of pharmaceutical products (such as ATMP and Clinical batches and related activities
EU Certification and release of pharmaceutical product batches and all associated processes
Quality control of pharmaceutical products
Participate in inspections and client audits, subcontractors, and suppliers, as dictated by corporate initiatives
Ensure the qualified status of premises, equipment, suppliers, and personnel involved in pharmaceutical activities.
Ensure compliance to regulations related to the scope of the role in collaboration with RA manager

Main Duties:

Batch record reviews and certification of products for release in EU (and UK with UK QP).
Review Master Batch Record with client
Oversees the preparation of internal batch records. Plan and coordinate QA operational team activities, ensuring compliance with procedures and proper staff qualification.
Perform and document quality control activities related to the department’s scope.
Review external auditors’ reports.
Lead and manage the site’s pharmaceutical operations and QA personnel.
Oversee operations and day to day management of quality team.
Manage Deviations, CAPAs.
Evaluates and tracks change controls related to their scope of activity.
Review, and approve procedures and work instructions.
Prepare batch documentation.
Contribute to the preparation of regulatory dossiers.
Support the implementation of site projects to align with the company systems to include Veeva and MyCellHub.
Audit subcontractors and client pharmaceutical manufacturing sites & QC Departments Participate in inspections and client audit
Define and monitor performance and workload indicators for the QA Operation department.
Participate in the site Operation management committee.

Required Skills & Experience:

Minimum 5 years’ experience in pharmaceutical manufacturing (industrial environment)
At least 5 years’ experience in quality assurance (QA) and regulatory compliance (RC) within the pharmaceutical sector
Must be eligible for registration in Section B of the French National Council of Pharmacists (Conseil National de l’Ordre des Pharmaciens, CNOP)
Must be a French Qualified Person (QP) Interim Responsible Person
Must have experience working as a Quality Operations Manager or Head of Quality Operations or Head of Pharmaceutical Operations or equivalent job title for a minimum of 5 years, ideally having worked in a CDMO.
Experience of ATMP, vaccines or clinical batches or Sterile Injectables or Mammalian Cell or Cell and Gene therapy or Immunotherapy or Pharmaceutical Aseptic process
Fluent in English and French language both written and verbal
Solid understanding of pharmaceutical regulatory frameworks (GMP, GLP, etc.)
Nice to have: Strong knowledge of ISO 9001 standards ?

Personal Attributes:

Strong organisational skills, attention to detail, and a logical approach
Excellent interpersonal, leadership and management skills
Ability to work collaboratively in an international team environment.
Proactive mindset and ability to take initiative.
Must be a self-starter, pragmatic in approach and a true problem solver with the ability to work autonomously and proactively.
Strong written communication skills
Must be excellent in Client liaison.

About Company

Our Client is a leading supply chain partner for the life sciences industry, providing specialized solutions that support the unique needs of the biopharmaceutical, cell and gene therapy, reproductive medicine, and animal health sectors.

Operations

France

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