Senior Clinical QA Manager – GCP & Compliance (Remote)

Barrington James; Saint-Louis; Hybride; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Barrington James is seeking a Clinical Quality Assurance Manager in Saint-Louis, France (remote considered, local preferred). You will own GCP QA activities across a global clinical programme, ensuring participant protection, data integrity and inspection readiness.

Reporting to the Head of QA, you will collaborate with Clinical Operations, Medical, Regulatory, Biometrics and CROs, combining hands-on execution with independent oversight.

Qualifications

• 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.

Responsabilités

• 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 GxP computerised systems and data integrity, applying ALCOA++ principles.
• Deliver pragmatic QA advice and role-based training across the organisation.

Connaissances

GCP QA

CAPA management

Audits

GxP systems

Regulatory knowledge

Formation

Life sciences degree

Description du poste

Barrington James is seeking a Clinical Quality Assurance Manager in Saint-Louis, France (remote considered, local preferred). You will own GCP QA activities across a global clinical programme, ensuring participant protection, data integrity and inspection readiness.

Reporting to the Head of QA, you will collaborate with Clinical Operations, Medical, Regulatory, Biometrics and CROs, combining hands-on execution with independent oversight.