Global Sterility Assurance Systems & Standards Lead

CSL SEQIRUS

Multiple Locations
Sterility assurance oversight
Microbial contamination control strategy
Regulatory expectations
This strategic position 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 position 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.
  • The company is a global biotherapeutics leader driven by its promise to save lives, focused on serving patients’ needs by using the latest technologies.

Matching Summary

This strategic position 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 expectations
  • inspection readiness
  • CMO Sterility Support

Nice-to-have

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

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