The C&Q Lead is responsible for developing and executing the global commissioning and qualification strategy for Tier 1 capital projects across the biopharmaceutical network
Job Summary
The C&Q Lead is responsible for developing and executing the global commissioning and qualification strategy for Tier 1 capital projects across the biopharmaceutical network.
This role ensures compliance with regulatory standards (FDA, EMA, ASTM E2500), drives harmonization of C&Q practices, and provides technical leadership to site engineering teams.
The position also includes establishing strategic partnerships with external C&Q execution vendors and ensuring readiness for regulatory inspections.
Matching Summary
The C&Q Lead is responsible for developing and executing the global commissioning and qualification strategy for Tier 1 capital projects across the biopharmaceutical network.
Skills & Requirements
Must-have
global commissioning and qualification strategy
biopharmaceutical network compliance
harmonization of C&Q practices
technical leadership to site teams
strategic shift in operating model
partnership governance
external partner integration
Nice-to-have
digital C&Q platforms
data analytics tools
global mindset
matrix organization competency
risk-based approaches
automation in C&Q processes
Key Requirements
Bachelor’s or Master’s degree in Engineering
12+ years in GMP-regulated pharmaceutical manufacturing