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 and GDP regulations.
Role type
Senior IC Quality Assurance Manager
Builds
Quality Management Systems (QMS) and regulatory compliance for emerging biotech commercialization
Domain
Life Sciences / Pharmaceutical / Regulatory Affairs
Required skills
GMP and GDP compliance, SOP creation and review, vendor management and auditing, root cause analysis, change control, deviation and complaint handling, recall operations, risk-based decision making
Preferred skills
Pharmacist degree, regulatory inspection experience, quality function representative experience
Technologies
GxP, QMS, CAPA systems
Responsibilities
Design and maintain the quality system; initiate and review SOP updates; oversee vendor management and lead audits; ensure compliance with GMP/GDP; manage change control, deviations, and complaints; participate in self-inspections and recalls; support management reviews for continuous improvement.
Seniority
Senior, hands-on IC