Manager Senior Quality Compliance H/F
Core
Senior manager responsible for quality and compliance activities at a major vaccine manufacturing site in France, serving as the liaison between the site, global functions, and external authorities.
Role type
Senior IC Quality Compliance Manager
Builds
Vaccine production facilities and regulatory compliance systems
Domain
Biopharmaceuticals / Vaccines / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Pharmaceutical Quality Management, Regulatory Affairs, Audit & Inspection Management, Supplier Quality Management, CAPA Management, Product Transfer & Stability Support, Root Cause Analysis, GMP Compliance
Preferred skills
Team Leadership & Coaching, Matrix Organization Experience, Combined Products/MD Device Compliance, National Inspection Readiness
Technologies
GxP Regulations, Digital Fluency, Lean Management, Technical Writing
Responsibilities
Supervise internal audit/inspection teams and supplier quality teams; Lead continuous improvement projects to strengthen quality systems; Coordinate responses to regulatory authorities and clients; Review and approve quality documentation including Quality Agreements and Site Master Files; Pilot investigations into deviations and market complaints; Collaborate with EHS teams to integrate safety requirements.
Seniority
Senior, hands-on IC with management responsibilities
