Regulatory standards compliance (fda, ema, astm e2500)
Harmonization of c&q practices
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.
CSL Behring is a global biotherapeutics leader driven by our promise to save lives, focused on serving patients’ needs by using the latest technologies.
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
Regulatory standards compliance (FDA, EMA, ASTM E2500)
Harmonization of C&Q practices
Technical leadership to site engineering teams
Commercial partnerships with C&Q execution firms
Risk-based approaches and automation
Nice-to-have
Global mindset and matrix organization
Digital C&Q platforms and data analytics
Biologics, cell & gene therapy, or sterile manufacturing
Key Requirements
Bachelor's or Master's degree in Engineering
12+ years in GMP-regulated pharmaceutical manufacturing
8 years in leadership roles managing global programs