Clinical Quality Assurance Manager

Clinical Quality Assurance Manager - Saint-Louis, France (Remote considered, local preferred)

Si vous voulez connaître les exigences de ce poste, poursuivez votre lecture pour toutes les informations pertinentes.

Our client is a clinical-stage biotech developing a novel oral therapy for patients with a serious blood cancer, currently running a pivotal global clinical trial

The Role

Reporting to the Head of Quality Assurance, you'll take ownership of key GCP QA activities across a global clinical programme, providing independent, risk-based quality oversight that keeps trial-participant protection, data integrity and inspection readiness front and centre.

You'll work closely with Clinical Operations, Medical, Regulatory, Biometrics and CMC, as well as CROs and other service providers - combining hands‑on execution with the independence to challenge and escape when it matters.

What You'll Do

• Own assigned QMS processes, controlled documents and their ongoing improvement.
• Manage quality events, investigations and CAPAs from intake through to defensible closure, challenging weak conclusions where needed.
• Support risk-based qualification and oversight of CROs and other service providers, including review of quality agreements and escalation pathways.
• Provide QA input into clinical‑trial risk management, including Critical‑to‑Quality factors and associated controls.
• Plan, conduct and follow up on risk-based audits, internal, service‑provider and site‑level.
• Support continuous inspection readiness, including readiness assessments and inspection response.
• Provide QA oversight of Gx P computerised systems and data integrity, applying ALCOA++ principles.
• Deliver pragmatic QA advice and role‑based training across the organisation.
• What You'll Bring
• A degree in pharmacy, life sciences, medicine, nursing or a related scientific discipline (or equivalent experience).
• 7+ years in clinical research, biotech or pharma, including 4+ years in a GCP quality assurance role.
• Hands‑on experience managing quality events, investigations, root‑cause analysis and CAPAs.
• Practical experience with service‑provider oversight and GCP audits, including reporting and follow‑up.
• Strong working knowledge of ICH GCP E6(R3), the EU Clinical Trials Regulation and FDA GCP expectations.
• Fluent written and spoken English.
• Nice to Have
• Sponsor‑side experience on multinational Phase II/III or registration‑enabling trials, ideally in oncology or haematology.
• Qualified or experienced GCP lead auditor.
• Experience overseeing Gx P computerised systems, electronic records and audit trails.
• Familiarity with GMP/GDP interfaces and pharmacovigilance quality processes.
• Experience supporting FDA, MHRA and/or EMA/EU Member State inspections.
• Why Join

This is a hands‑on role in a small, focused biotech advancing a pivotal treatment for patients with limited options, with real autonomy, direct senior‑leadership access, and genuine influence over how the quality function is shaped as the company grows.

Based in the Saint-Louis area of France, with remote considered for the right candidate (local presence preferred). xzragkv Occasional travel required, including for audits and inspections.

#J-18808-Ljbffr