Global Commissioning & Qualification Lead

cslbehring.de

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.
  • Key responsibilities include 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
  • Biopharmaceutical network compliance
  • Harmonization of C&Q practices
  • Technical leadership to site engineering
  • Partnered model for C&Q execution
  • Regulatory inspection readiness

Nice-to-have

  • Biologics, cell & gene therapy experience
  • Digital C&Q platforms and data analytics
  • Global mindset and matrix organization
  • Risk-based approaches and automation

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, ISPE guidelines

Work Rights

Not specified

Tailored Resume

Cover Letter