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.
The position also includes establishing strategic partnerships with external C&Q execution vendors and ensuring readiness for regulatory inspections.
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
Partnered C&Q execution model
Commercial partnerships with C&Q firms
Risk-based approaches and automation
Nice-to-have
Biologics, cell & gene therapy experience
Digital C&Q platforms and data analytics
Global mindset and matrix organization
Continuous improvement mechanisms
Key Requirements
Bachelor's or Master's degree in Engineering
12+ years in GMP-regulated pharmaceutical manufacturing
Minimum 8 years in leadership roles managing global programs
PMP or equivalent certification
Deep knowledge of ASTM E2500, ISPE Baseline Guides