Senior Manager Quality Assurance / Qualified Person (all genders) in Le Havre

The Senior Manager Quality Assurance / Qualified Person (QP) is responsible for ensuring that all medicinal products and investigational medicinal products are manufactured, imported, tested, certified, and distributed in accordance with EU GMP, GDP, applicable Dutch and EU regulatory requirements, and company quality standards.

The role serves as a Qualified Person and will support or perform batch certification and release activities in accordance with Article 51 of Directive 2001/83/EC and applicable Dutch legislation, ensuring that products placed on the market meet all regulatory and quality requirements.

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• Serve as the local Quality Assurance lead, ensuring compliance with GMP, GDP, EU and local regulatory requirements, and company quality standards.
• Maintain and continuously improve the Quality Management System (QMS) in collaboration with the Director QA EMEA.
• Act as a registered Qualified Person and perform batch certification and release activities (where delegated).
• Ensure the quality and regulatory compliance of imported medicinal products and investigational medicinal products, including review of batch documentation.
• Manage key quality processes, including but not limited to deviations, CAPAs, change controls, complaints, supplier quality, quality agreements, and document management.
• Qualify and oversee suppliers, manufacturers and contractors, ensuring effective quality oversight of external partners and supply chains.
• Prepare for and support regulatory inspections, customer audits, and supplier audits, maintaining continuous inspection readiness.
• Investigate quality events, implement effective CAPAs, monitor quality metrics, and drive continuous improvement and a culture of quality and compliance.
• Provide QA guidance and support to internal stakeholders and external partners, escalating critical quality and compliance issues where appropriate.
• Master's degree in pharmacy, Pharmaceutical Sciences, Chemistry, Biology, Biotechnology, or related Life Sciences discipline.
• Qualified Person (QP) status in the Netherlands or eligibility to act as a Qualified Person under applicable EU and Dutch regulatory requirements.
• Additional training or certifications in GMP, GDP, Quality Systems, Auditing, or Pharmaceutical Quality Management are preferred.
• Minimum 5 years of experience in Pharmaceutical Quality Assurance in a GMP-regulated environment.
• Demonstrated experience with Quality Management Systems (deviations, investigations, CAPA, change control, risk management, document management).
• Experience with medicinal products and specifically investigational medicinal products, including imported products from third countries; knowledge of small molecules, synthetic oligonucleotides and peptides is an advantage.
• Sound knowledge of EU GMP, GDP, ICH guidelines, applicable European pharmaceutical regulations, the Dutch medicines act and other relevant national legislation.
• Experience supporting regulatory inspections and customer and supplier audits.
• Strong organizational, communication, stakeholder management, and technical documentation skills.
• Ability to work independently in a global, cross-functional environment with a proactive, solution-oriented mindset.
• Fluent in English (written and spoken); Dutch is an advantage.
• Proficient in Microsoft Office (Excel, Word, Outlook, Power Point).

Physical Requirements

• Ability to work in an office environment with occasional visits to GMP operational areas.
• Ability to perform routine site activities, including extended computer work and occasional lifting of up to 10 kg.

An Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. xzragkv Employees holding this position will be required to perform any other job‑related duties as requested by Management.

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