Senior Manager Quality Operations (m/f/d)
Core
Ensure quality and compliance throughout the lifecycle of innovative biosimilar and combination products in a highly regulated environment.
Role type
Senior Manager, Quality Operations
Builds
GMP-compliant transition of programs from development to commercial; tech transfer and analytical transfer of manufacturing activities
Domain
Biotechnology / Life Sciences / Pharmaceuticals
Required skills
cGxP regulation knowledge, GMP compliance management, Change Control/Deviation/CAPA management, Supplier quality oversight (C(D)MOs, Labs, Medical Devices), Regulatory agency experience (FDA, EMA), Technical degree (Bachelor/Master/PhD)
Preferred skills
German and/or French language proficiency
Technologies
ISO 9001, ISO 13485, ICH Q8, ICH Q9, ICH Q10
Responsibilities
Implement cGxP requirements into local procedures (SOPs, Guiding Documents), Manage GMP compliance during tech transfer and analytical transfer, Manage internal and external Change Controls, Deviations, Events, CAPAs, Manage GMP/GDP/MDR quality oversight of suppliers and partners
Seniority
Senior, Management
