Global Sterility Assurance Systems & Standards Lead

CSL BEHRING

Multiple Locations
Sterility assurance oversight and support
Microbial contamination control strategy
Aseptic excellence
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 and support
  • microbial contamination control strategy
  • aseptic excellence
  • regulatory expectations
  • global inspection readiness

Nice-to-have

  • strategic leadership
  • proactive risk management
  • culture and continuous improvement
  • collaboration across functions

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter