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, drives harmonization of C&Q practices, and provides technical leadership to site engineering teams while championing a strategic shift to a highly partnered execution model.
CSL Behring is a global biotherapeutics leader committed to innovation and inclusion, operating one of the world’s largest plasma collection networks and delivering therapies to more than 100 countries.
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
Innovation in C&Q lifecycle management
Key Requirements
Bachelor’s or Master’s degree in Engineering
12+ years in GMP-regulated pharmaceutical manufacturing