Quality Assurance Manager (m/f/d)
Core
Ensuring compliance with EU Good Distribution Practices (GDP) guidelines, maintaining Wholesaler Distribution Authorization (WDA), and managing the Quality Management System (QMS) for a global pharmaceutical trading entity.
Role type
Senior IC Quality Assurance Manager (Pharmaceutical Distribution)
Builds
Maintains Distribution Quality Systems and ensures inspection readiness for medical products.
Domain
Pharmaceutical industry + EU regulatory compliance (GDP)
Required skills
GDP compliance, Quality Management Systems (QMS), Regulatory inspections, Supplier/Customer approval, Technical agreements, Quality audits, CAPA implementation, Batch disposition decisions, Project management
Preferred skills
Spanish language proficiency, Multitasking in complex matrix environments
Technologies
GDP documentation systems, QMS platforms
Responsibilities
Writing GDP-related SOPs and managing documentation; Verifying medical products and ensuring process compliance; Approving suppliers, customers, and third-party activities; Managing technical agreements with third parties; Managing regional and global Distribution Centers; Assessing deviations from storage/transportation and implementing CAPA; Monitoring QMS for releases; Performing audits of Logistic Service Providers; Acting as Responsible Person Delegate for batch disposition decisions; Supporting continuous improvement of the QMS.
Seniority
Senior, hands-on IC
