Leiter der Herstellung (m/w/d)
Core
Leading the manufacturing department and validating manufacturing and cleaning processes for pharmaceutical products.
Role type
Senior manufacturing department head (pharmaceuticals)
Builds
Pharmaceutical products (ATMP, biologics implied by Annex 1/4)
Domain
Pharmaceuticals / Biotechnology
Required skills
GMP compliance, regulatory affairs, team leadership, budget management, process validation, deviation management, project management
Preferred skills
FDA experience, Annex 1 and Annex 4 knowledge, business acumen
Technologies
GMP systems, ERP/Controlling tools
Responsibilities
Organize and oversee the manufacturing department, ensure GMP and regulatory compliance, manage budget and resources, lead and develop ~20 employees, prepare for regulatory inspections, collaborate with QC/QA/Engineering
Seniority
Senior, hands-on IC with people management
