Responsable Assurance Qualité Post Market H/F
Core
Lead post-market quality assurance for sterile injectable aesthetic products, managing global supply chain quality, safety surveillance, and supplier strategy.
Role type
Senior Quality Assurance Manager (Post-Market)
Builds
Global supply chain quality assurance, safety surveillance programs, supplier quality systems
Domain
Pharmaceutical / Medical Aesthetics
Deliverable
client delivery
Required skills
Post-market surveillance strategy, PSUR/PMCF management, complaint handling, supplier quality management, quality system implementation, major quality event coordination, stability program management, trend analysis, audit management, budget management, team leadership
Preferred skills
FDA/ISO13485 regulatory knowledge, scientific degree, English fluency
Technologies
None stated
Responsibilities
Act as primary quality representative for global supply chain; Supervise post-market surveillance strategy including PSUR and PMCF; Manage complaint handling and market signal review; Oversee supplier quality strategy; Implement and maintain quality system effectiveness; Coordinate major quality events; Manage stability programs; Lead trend reviews and quality recommendations; Conduct audits and KPI tracking; Manage service budget; Lead multidisciplinary quality team
Seniority
Senior, hands-on IC with management responsibilities