Director of Quality Pharmaceutical Operations
2 days ago
Louvres
Our Client Our client is a leading global supply chain partner to the life sciences industry, delivering specialist solutions to organisations operating across biopharmaceuticals, cell and gene therapy, reproductive medicine and animal health. Their fully integrated offering includes temperature-controlled logistics, BioServices, biostorage, cryopreservation and consulting, helping customers maintain the highest levels of quality, precision and reliability throughout the pharmaceutical supply chain. With decades of industry expertise and a strong focus on innovation, they play a vital role in supporting the delivery of life-changing therapies, advanced treatments and critical healthcare products around the world. Role Overview Build Something From the Ground Up This is an exceptional opportunity for an experienced Head of Quality Operations, Quality Operations Manager or senior pharmaceutical QA professional to take ownership of the quality function at a brand-new pharmaceutical logistics site in Louvres, France. Rather than stepping into an established operation, you'll have the rare opportunity to build the pharmaceutical quality and operational framework from the ground up. You'll have significant autonomy and the opportunity to shape the site's quality systems, processes, procedures and ways of working, working closely with internal teams, clients and senior stakeholders as the operation develops. Initially, batch release activities will not form part of the role. However, as the site grows and new pharmaceutical clients are onboarded, responsibility for EU batch certification and release will become an important part of the position. This is an ideal opportunity for someone who thrives on ownership, autonomy and building high-performing pharmaceutical operations, and who wants to have a genuine influence on the future success of a new site. If you're ready to take your pharmaceutical quality career to the next level and build something from the ground up, this could be the opportunity you've been waiting for. Key Responsibilities: The postholder is accountable for: • Receipts of ATMP’s and expedition of the products., • Importation of pharmaceutical products from the USA, Asia to the EU., • EU Certification and release of pharmaceutical product batches and all associated processes, • Quality control of pharmaceutical products, • Quality assurance related to all pharmaceutical activities within the organisation., • Organise, support, and manage the company’s pharmaceutical activities., • Ensuring all pharmaceutical operations comply with applicable regulations., • Implement and maintain the Pharmaceutical QMS in line with the company quality policy and applicable regulations., • Manage Inspection of Health Authority (ANSM), • Manage audits of clients, subcontractors, and suppliers, • Maintain the qualified status of premises, equipment, suppliers, and personnel involved in pharmaceutical activities., • Ensure compliance with Regulatory affairs 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 external auditors’ reports., • Oversee operations and day-to-day management of the quality team., • Lead and manage the site’s pharmaceutical activities department and personnel., • Perform and document quality control activities related to the department’s scope, • Establish and maintain the Quality Management System (QMS), including deviations, CAPA, change control, internal audits, batch record review, staff training, equipment qualification/validation, supplier qualification, and personnel authorisation., • Manage CAPAs, initiate deviations, and oversee change control processes within the department., • Draft, review, and approve procedures and work instructions., • Plan and coordinate operational team activities, ensuring compliance with procedures and proper staff qualification., • Prepare batch documentation., • Contribute to the preparation of regulatory dossiers., • Support the implementation of site projects to align with the company systems, including Veeva (eDMS/eQMS) and MyCellHub (inventory management)., • Conduct client audits and host inspections from health authorities., • Audit subcontractors and client pharmaceutical manufacturing sites & QC Departments., • Define and monitor performance and workload indicators for the department., • Participate in the Louvres leadership/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 have Section B of the French National Council of Pharmacists (Conseil National de l’Ordre des Pharmaciens, CNOP), • Must be a French Qualified Person (QP), • Must have experience working as a Site Director, Quality Operations Manager, or Head of Quality Operations, or Head of Pharmaceutical Operations or an equivalent job title for a minimum of 5 years, ideally having worked in a CDMO., • Experience with vaccines or clinical batches or ATMP or Sterile Injectables or Mammalian Cell or Cell and Gene therapy or Immunotherapy or Pharmaceutical Aseptic process, • Fluent in English and French languages, 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, • Ability to build, lead and retain a QA operations team., • Excellent interpersonal, leadership and management skills., • Ability to work collaboratively in an international team environment., • Proactive mindset and ability to take initiative., • Strong written communication and presentation skills., • Must be a self-starter, pragmatic in approach and a true problem solver with the ability to work autonomously and proactively., • Must be excellent at client liaison.
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