Global Sterility Assurance Systems & Standards Lead

CSL Behring

Sterility assurance oversight and support
Microbial contamination control strategy
Regulatory and csl standards adherence
This strategic 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 strategic 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 strategic 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
  • regulatory and CSL standards adherence
  • major deviation investigations
  • inspection readiness for sites
  • CMO and filling strategies support
  • aseptic excellence

Nice-to-have

  • strategic leadership
  • continuous improvement culture
  • business intelligence
  • holistic approach
  • proactive risk management
  • collaboration across functions

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter