Operational QA Manager

We are seeking an experienced Operational QA Manager to lead and develop the Quality Assurance function at our Lille manufacturing site, specialising in aseptic filling operations. Reporting to site leadership, you will manage a sizeable team (~60 people) and ensure robust compliance with cGMP, EU Annex 1, and all relevant regulatory standards.

This is a key leadership role, directly influencing product quality, regulatory readiness, and the continuous improvement of QA systems.

Key Responsibilities

• Lead, mentor, and develop a large QA team, ensuring clarity of objectives, performance standards, and career growth paths
• Oversee day‑to‑day operational QA activities, particularly in aseptic manufacturing environments
• Maintain and improve site compliance with applicable GxP requirements and internal quality systems
• Partner with production, QC, and engineering teams to ensure consistent GMP execution across operations
• Serve as the QA decision‑maker in deviation investigations, change controls, and batch disposition processes
• Drive inspection readiness and act as a point of contact during regulatory audits (EMA, ANSM, FDA)
• Contribute to the site's Annex 1 compliance strategy, particularly in relation to contamination control and aseptic practices
• Support continuous improvement initiatives, embedding quality culture across the organisation

Required Experience & Skills

• Proven leadership experience managing large QA teams in a GxP manufacturing environment
• Solid expertise in aseptic filling operations
• Fluent French (business‑critical; all site operations in French)
• Strong interpersonal skills with the ability to engage effectively across all levels of the organisation

Desirable

• Experience with isolator technology
• Strong working knowledge of EU Annex 1 requirements
• Pharmacist degree (preferred but not required)

What We Offer

• Opportunity to lead a high‑impact quality function in a key manufacturing site
• Collaborative environment with committed leadership and a strong quality culture
• Competitive remuneration and benefits package