Director Quality / Qualified Person (QP) (m/f/d)
Core
Lead the Quality organization and act as Qualified Person to ensure compliance with EU GMP and national regulations for medicinal product release.
Role type
Director Quality / Qualified Person (QP)
Builds
Pharmaceutical products for hospital-based treatments in anesthesiology, intensive care, and infectious diseases
Domain
Pharmaceutical / GMP / Regulatory Compliance
Required skills
EU GMP/GDP knowledge, Pharmaceutical Quality Systems, batch certification, regulatory inspections, leadership, cross-functional quality improvement
Preferred skills
Microsoft Office, electronic Quality Management Systems
Technologies
electronic Quality Management Systems
Responsibilities
Ensure effectiveness and compliance of the Pharmaceutical Quality System; Drive quality strategy and operational excellence; Oversee key quality systems including deviations, CAPAs, and change controls; Perform batch certification and release of medicinal products; Review and evaluate batch documentation and release-relevant quality records; Support and represent Quality during regulatory inspections and customer audits
Seniority
Director, strategic leadership & hands-on QP responsibilities
