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.
CSL Behring is a global biotherapeutics leader focused on innovative therapies and operates one of the world’s largest plasma collection networks.
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
Compliance with FDA, EMA, ASTM E2500
Management of multi-site C&Q programs
Change management for operating model transition
Vendor partnership and contract negotiation
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
Risk-based C&Q methodologies
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 C&Q programs
PMP or equivalent certification
Deep knowledge of ASTM E2500 and ISPE Baseline Guides