CQV Manager - Pharmaceutical Manufacturing
Core
Lead commissioning, qualification, and validation (CQV) strategies and execution for large-scale pharmaceutical manufacturing capital projects, ensuring GMP compliance and operational readiness.
Role type
Senior CQV Manager (Pharmaceutical Manufacturing)
Builds
Commissioned and qualified pharmaceutical manufacturing facilities, utilities, and automation systems for greenfield projects.
Domain
Pharmaceutical manufacturing / Life sciences / GMP-regulated facilities
Required skills
CQV strategy development, Validation Master Plan (VMP) creation, FAT/SAT execution, GMP compliance, project leadership, stakeholder management, team management, regulatory standards knowledge (FDA/EMA/ISPE), facility startup support
Preferred skills
Experience with Singapore pharmaceutical projects, managing external contractors, operator training coordination, multidisciplinary team leadership in complex environments
Technologies
GMP, FDA, EMA, ISPE, ASTM, GAMP, automation systems, clean utilities, process equipment
Responsibilities
Develop and implement commissioning and qualification strategies; Lead CQV planning and execution across process, utility, and automation systems; Manage CQV teams and external contractors; Ensure compliance with regulatory standards; Support facility startup and operational handover
Seniority
Senior, hands-on IC with leadership responsibilities
