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 engineering
Define and implement global C&Q standards
Lead C&Q scope for major capital projects
Nice-to-have
Champion transformation of operating model
Establish strategic partnerships with vendors
Build technical capabilities and mentor SMEs
Benchmark industry best practices
Drive risk-based approaches and automation
Key Requirements
Bachelor’s or Master’s degree in Engineering
12+ years in GMP-regulated pharmaceutical manufacturing
8 years in leadership roles managing global or multi-site C&Q programs
PMP or equivalent certification
Deep knowledge of ASTM E2500, ISPE Baseline Guides