Global Commissioning & Qualification Lead

CSL BEHRING

Hybrid
Global commissioning and qualification strategy
Biopharmaceutical network compliance
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
  • Biopharmaceutical network compliance
  • Harmonization of C&Q practices
  • Partnership governance
  • External partner integration
  • Risk-based C&Q approaches

Nice-to-have

  • Digital C&Q platforms
  • Data analytics tools
  • Global mindset
  • Matrix organization competency

Key Requirements

  • Bachelor's or Master's degree in Engineering
  • 12+ years in GMP-regulated pharmaceutical manufacturing
  • 8 years in leadership roles managing global C&Q programs
  • PMP or equivalent certification
  • Deep knowledge of ASTM E2500 and ISPE guidelines

Work Rights

Not specified

Tailored Resume

Cover Letter