Global Sterility Assurance Systems & Standards Lead

CSL Behring

Sterility assurance oversight
Microbial contamination control strategy
Regulatory and csl standards adherence
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.
  • 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

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 CSL standards adherence
  • major deviation investigations
  • inspection readiness
  • CMO and filling strategies support
  • aseptic excellence collaboration

Nice-to-have

  • strategic leadership development
  • business intelligence gathering
  • proactive risk management
  • culture of curiosity and empathy

Key Requirements

  • Bachelor’s degree in microbiology or biology or life sciences
  • 8-10 years' pharmaceutical manufacturing experience
  • Quality assurance within manufacturing and QC microbiology
  • GxP, FDA, EU regulatory guidelines
  • Interacting with regulatory authorities

Work Rights

Not specified

Tailored Resume

Cover Letter