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.
The position also includes establishing strategic partnerships with external C&Q execution vendors and ensuring readiness for regulatory inspections.
At CSL, Inclusion and Belonging is at the core of our mission and who we are.
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
Partnered C&Q execution model
Regulatory inspection readiness
Risk-based C&Q approaches
Nice-to-have
Digital C&Q platforms
Data analytics tools
Global mindset
Matrix organization competency
Key Requirements
Bachelor’s or Master’s degree in Engineering
12+ years in GMP-regulated pharmaceutical manufacturing
8 years in leadership roles managing global C&Q programs
PMP or equivalent certification
Deep knowledge of ASTM E2500, ISPE Baseline Guides