Louvres Site Quality Director & QP Delegate (Pharmacien Délégué)
il y a 4 jours
Louvres
Our Client 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. Role Overview The Pharmaceutical Activities Site Director is responsible for organising, managing, and overseeing all pharmaceutical operations and associated functions for a brand-new pharmaceutical logistics site based in Louvres, France. This is a very exciting opportunity for an experienced Head of Quality Operations, to build everything from scratch in a highly autonomous role. There is no batch release from the outset in this role, however, as new Clients are onboarded, there will be a requirement for batch release activities to be undertaken at a later stage in the site’s development. Key Responsibilities: The postholder is accountable for: • Receptions of ATMP’s and expedition of the products., • Importations 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, • Maintaining 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 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 or 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 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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