Global Sterility Assurance Systems & Standards Lead

CSL Behring

Sterility assurance oversight and support
Microbial contamination control strategy
Major deviation investigations
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.
  • Align and facilitate collaboration across Technical Operations, Quality functions, Operations, and R&D, to successfully drive aseptic excellence.

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 and support
  • microbial contamination control strategy
  • major deviation investigations
  • inspection readiness
  • CMO and filling strategies support
  • strategic CSL projects support

Nice-to-have

  • continuous improvement culture
  • proactive risk management
  • aseptic excellence collaboration

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter