Responsable Assurance Qualité - Pharmacien(ne) Délégué(e)
Core
Define and coordinate the Quality Assurance policy and ensure GMP compliance for aseptic formulation and filling of clinical, preclinical, and commercial pharmaceutical lots.
Role type
Senior Quality Assurance Manager (Pharmacist Delegate)
Builds
Clinical and commercial pharmaceutical lots (sterile and non-sterile), including immunoglobulins, cytotoxics, and vaccines.
Domain
Biopharmaceutical manufacturing (sterile/aseptic) and CDMO services.
Deliverable
Production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, aseptic manufacturing knowledge, risk management, regulatory affairs, team management, stakeholder representation.
Preferred skills
Experience in sterile manufacturing, cross-site project coordination, process optimization.
Technologies
GMP frameworks, regulatory databases, risk management tools.
Responsibilities
Define and implement Quality Assurance policy; Manage the QA team of 5; Ensure GMP compliance; Coordinate risk management; Represent the site with regulatory authorities and clients; Support product certification and release.
Seniority
Senior, hands-on IC with management responsibilities.
