Best Canditate
Our Client is a leading supply chain partner for the life sciences industry, providing specialised solutions that support the unique needs of the biopharmaceutical, cell and gene therapy, reproductive medicine, and animal health sectors.
Their fully integrated services include temperature-controlled logistics, BioServices, biostorage, cryopreservation, and consulting. Backed by decades of expertise and a comprehensive management platform, they enable their customers to deliver drug certainty, precision, and reliability throughout the supply chain, whether advancing life-changing therapies, supporting families on their reproductive journeys, or improving animal health.
Working: Hybrid Working between site and some work from home, with the ability to travel on occasion
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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
- Â 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.
