Quality Assurance Manager, Poland (Contractor)
Core
Designing, implementing, and maintaining the quality system for the South Cluster (Serbia, Croatia, Slovenia, Bosnia, Montenegro, Hungary) while ensuring compliance with GMP/GDP regulations.
Role type
Senior IC Quality Assurance Manager
Builds
Quality Management Systems (QMS) and regulatory compliance for pharmaceutical partners
Domain
Healthcare / Pharmaceutical / Regulatory Affairs
Required skills
GMP/GDP compliance, SOP creation and review, vendor auditing, root cause analysis, change control management, deviation handling, CAPA management, recall operations, risk-based decision making
Preferred skills
Pharmacist degree, regulatory inspection experience, quality function representative experience
Technologies
GxP, QMS, CAPA, Change Control
Responsibilities
Design and maintain the quality system; initiate and review SOP updates; oversee vendor management and auditing; ensure compliance with GMP/GDP; manage change control, deviations, and complaints; participate in regulatory inspections and recalls.
Seniority
Senior, hands-on IC