Global Sterility Assurance Systems & Standards Lead

CSL Behring

Not specified
Sterility assurance oversight
Gxp fda eu regulatory compliance
Microbial contamination control strategy
CSL Behring is seeking a Global Sterility Assurance Systems & Standards Lead to oversee sterility assurance compliance and standards across its global operations. The ideal candidate will have extensive experience in pharmaceutical manufacturing, particularly in quality assurance and regulatory compliance

Job Summary

  • This strategic leadership role executes sterility assurance oversight to ensure sites operate in compliance with the highest standard regulatory expectations.
  • The position drives consistent standards and proactive risk management by collaborating with global sterility assurance teams on microbial contamination control strategies.
  • CSL Behring is a global biotherapeutics leader driven by a promise to save lives through innovative therapies for immunology, hematology, and other therapeutic areas.

Matching Summary

Match Score: 85

CSL Behring is seeking a Global Sterility Assurance Systems & Standards Lead to oversee sterility assurance compliance and standards across its global operations. The ideal candidate will have extensive experience in pharmaceutical manufacturing, particularly in quality assurance and regulatory compliance.

Skills & Requirements

Must-have

  • Sterility assurance oversight
  • GxP FDA EU regulatory compliance
  • Microbial contamination control strategy
  • Aseptic filling and lyophilization expertise
  • CMO sterility support and selection

Nice-to-have

  • Strategic leadership in quality operations
  • Proactive risk management culture
  • Global inspection readiness experience
  • Collaboration across technical functions

Key Requirements

  • Bachelor's degree in microbiology or biology
  • 8-10 years pharmaceutical manufacturing experience
  • Direct QA experience in sterility assurance context
  • Experience interacting with FDA and EU regulatory agencies

Work Rights

Not specified

Tailored Resume

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