Dyrektor/ka ds. Jakości
Core
Overseeing the Quality Assurance system for a pharmaceutical distribution and production group, ensuring compliance with GMP, GDP, ISO, HACCP, and MDR regulations.
Role type
Senior Quality Assurance Director
Builds
Quality management systems and compliance frameworks for pharmaceutical operations
Domain
Pharmaceutical industry / Regulatory compliance
Required skills
Pharmaceutical/chemical/biological degree, 10+ years in QA/QC, team leadership, GMP/GDP/ISO/HACCP/MDR expertise, regulatory audit experience, English fluency, budget management, risk management
Preferred skills
Qualified Person (QP) authorization, multi-site experience, organizational integration experience
Technologies
GMP, GDP, ISO, HACCP, MDR
Responsibilities
Supervise the Quality Assurance system, prepare for inspections and audits, manage quality teams, set quality standards for facilities, oversee complaints and CAPA, manage quality risk and patient safety, participate in product withdrawal processes, support Pharmacovigilance, conduct supplier audits.
Seniority
Director level, strategic leadership
