Quality Assurance Manager (Clinical Trials)

Permanent (‘CDI’) – Lille, France – Hybrid

ABOUT OUR CLIENT

Our client is the French R&D division of a Swiss clinical-stage pharmaceutical company dedicated to identifying, developing, and commercialising novel antibacterial products for serious, life-threatening infections caused by multi-drug-resistant (MDR) bacteria.

The company is currently advancing a Phase 2 program in collaboration with esteemed partners such as the University of Lille and GlaxoSmithKline (GSK).

THE OPPORTUNITY

As part of a small, dynamic team based in Lille, France, the Quality Assurance Manager will play a key role in maintaining and enhancing the company’s Quality Management System (QMS) to ensure compliance with GCP and GVP.

Reporting to the Chief Development Officer and collaborating closely with internal teams and external partners, you will:

• Lead the inspection readiness program to ensure compliance with GCP standards.
• Oversee and improve the QMS to support clinical development activities.
• Conduct quality reviews of clinical development documents.
• Conduct internal and external audits and manage CAPAs.
• Qualify and manage suppliers and CROs, ensuring adherence to the company’s quality plan.
• Analyse and report on quality indicators.
• Provide training and support on GCP compliance to clinical and development teams.
• Ensure continuous regulatory compliance and keep the team informed of relevant updates.

YOUR PROFILE

• A degree in Life Sciences (Master’s, Engineer, Pharmacist, or PhD).
• Minimum 4 years’ experience in Quality Assurance, for clinical research or a similar role within a pharmaceutical company or CRO.
• Strong understanding of GCP and Quality Systems.
• Demonstrated expertise in operational QA for clinical activities.
• You have the autonomy, flexibility, and adaptability required to thrive in a dynamic biotech environment.
• You are a real team player with a friendly, positive attitude.
• You are comfortable taking on tasks beyond the initial scope and contributing to cross-functional projects.
• Fluent in English.
• French would be an advantage.

BENEFITS

• Competitive remuneration package.
• Opportunity to work in a cutting-edge biotech environment.
• Premises located within the Institut Pasteur, in the centre of Lille, close to all transport links.
• Remote work up to 2 days a week.
• Alternatively, 1 week of remote work per month would be considered.
• 10 additional paid leave days (‘jours de RTT’) on top of the statutory 25 days of annual leave.
• ‘Statut cadre’ Executive-level employment status with associated benefits.
• Occasional travel (4-5 times/year).

Ref : PR-0280