Global Sterility Assurance Systems & Standards Lead

CSL Behring

Sterility assurance oversight
Microbial contamination control strategy
Regulatory and business intelligence
This newly created leadership role executes Sterility Assurance oversight and support to CSL sites and CMOs to ensure that sites operate in compliance to the highest standard regulatory expectations

Job Summary

  • This newly created leadership role executes Sterility Assurance oversight and support to CSL sites and CMOs to ensure that sites operate in compliance to the highest standard regulatory expectations.
  • By driving sterility assurance across partnering functions, this position ensures consistent standards, proactive risk management, and global inspection readiness.
  • At CSL, Inclusion and Belonging is at the core of our mission and who we are.

Matching Summary

This newly created leadership role executes Sterility Assurance oversight and support to CSL sites and CMOs to ensure that sites operate in compliance to the highest standard regulatory expectations.

Skills & Requirements

Must-have

  • Sterility Assurance oversight
  • microbial contamination control strategy
  • regulatory and business intelligence
  • aseptic excellence
  • global inspection readiness

Nice-to-have

  • strategic leadership
  • proactive risk management
  • collaboration across functions
  • inclusion and belonging

Key Requirements

  • 8-10 years' experience
  • Bachelor’s degree in microbiology or biology or life sciences
  • GxP, FDA, EU regulatory guidelines
  • interacting with regulatory authorities

Work Rights

Not specified

Tailored Resume

Cover Letter