VP GMP Clinical Manufacturing Operations
Core
Lead global GMP Clinical Manufacturing Operations to ensure on-time scale-up, manufacture, and supply of high-quality, GMP-compliant products for clinical trials across 6 sites in 4 countries.
Role type
VP, Global GMP Clinical Manufacturing Operations (Senior Leadership)
Builds
Drug Substance and Drug Product pilot plants, multi-modality processes, and clinical supply for R&D trials.
Domain
Pharmaceutical/Biotechnology, Clinical Manufacturing, GMP
Required skills
GMP manufacturing operations, cross-modality drug development, line leadership of global scientific functions, capital project oversight, organizational change management, strategic workforce planning, financial acumen, regulatory compliance, manufacturing automation, risk management.
Preferred skills
PhD in Engineering/Pharmaceutical Sciences, experience leading leaders in complex matrix organizations, influencing at senior governance boards, strategic partnership development, deep understanding of pharmaceutical development risks and failure modes.
Technologies
Manufacturing automation, CMC Digital Strategy tools, pilot plant control systems.
Responsibilities
Lead global department of ~300 staff across 6 sites; drive modernization and digitalization of GMP operations; oversee major capital projects (e.g., Marietta Steriles, UM Flex Factory); manage technical investment proposals; monitor external CMO landscape; implement strategic workforce plans; lead significant change programs.
Seniority
VP, Strategic Leadership & Global Operations