Global Sterility Assurance Systems & Standards Specialist

Chlworks

Sterility assurance standards
Microbial contamination control strategy
Regulatory and csl standards adherence
Provides strategic leadership to the site related to sterility assurance standards, culture and continuous improvement

Job Summary

  • Provides strategic leadership to the site related to sterility assurance standards, culture and continuous improvement.
  • Partners closely with the global function leads as well as site leadership team, develops strategies to ensure continuous adherence to regulatory and CSL standards related to sterility assurance governance and drive improvements.
  • 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

Provides strategic leadership to the site related to sterility assurance standards, culture and continuous improvement.

Skills & Requirements

Must-have

  • sterility assurance standards
  • microbial contamination control strategy
  • regulatory and CSL standards adherence
  • sterile filtration, aseptic filling, lyophilization
  • inspection readiness
  • CMO support and filling strategies

Nice-to-have

  • strategic leadership
  • continuous improvement culture
  • holistic approach
  • proactive role in investigations
  • stakeholder collaboration

Key Requirements

  • Bachelor's degree in Microbiology or Biology or life sciences
  • 8-10 years' experience in pharmaceutical manufacturing
  • direct experience in QA, QC microbiology, sterility assurance
  • GxP, FDA, EU regulatory guidelines
  • experience interacting with regulatory authorities

Work Rights

Not specified

Tailored Resume

Cover Letter