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 drives the transition to a highly partnered C&Q execution model and ensures compliance with regulatory standards including FDA, EMA, and ASTM E2500.
CSL Behring is a global biotherapeutics leader focused on innovative therapies and fostering an inclusive culture that supports diversity and belonging.
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 leadership
Regulatory compliance with FDA and EMA
C&Q execution for capital projects
Vendor and commercial partnership management
Risk-based C&Q methodologies
Technical leadership for site engineering teams
Nice-to-have
Experience with biologics and cell & gene therapy
Familiarity with digital C&Q platforms
Global mindset and matrix organization experience
Mentoring and capability building
Change management expertise
Key Requirements
Bachelor’s or Master’s degree in Engineering
12+ years GMP pharmaceutical manufacturing experience