Global Sterility Assurance Systems & Standards Specialist

CSL Behring

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Sterility assurance standards
Microbial contamination control strategy
Regulatory and csl standards adherence
** CSL Behring is seeking a Global Sterility Assurance Systems & Standards Specialist to provide strategic leadership in sterility assurance, ensuring compliance with regulatory standards and continuous improvement. The ideal candidate should possess a strong background in microbiology and quality assurance within a pharmaceutical manufacturing context, with significant experience in regulatory interactions. This role offers an opportunity to impact patient care through innovative therapies while promoting a culture of inclusion and belonging. **

Job Summary

  • Provides strategic leadership to the site related to sterility assurance standards, culture and continuous improvement.
  • Work collaboratively with the global sterility assurance teams to provide a holistic microbial contamination control strategy and improvement plan at the site.
  • CSL Behring is a global biotherapeutics leader driven by our promise to save lives.

Matching Summary

Match Score: 75

** CSL Behring is seeking a Global Sterility Assurance Systems & Standards Specialist to provide strategic leadership in sterility assurance, ensuring compliance with regulatory standards and continuous improvement. The ideal candidate should possess a strong background in microbiology and quality assurance within a pharmaceutical manufacturing context, with significant experience in regulatory interactions. This role offers an opportunity to impact patient care through innovative therapies while promoting a culture of inclusion and belonging. **

Skills & Requirements

Must-have

  • sterility assurance standards
  • microbial contamination control strategy
  • regulatory and CSL standards adherence
  • sterile filtration
  • aseptic filling
  • lyophilization
  • sterility testing
  • media fill testing
  • bioburden testing

Nice-to-have

  • strategic leadership
  • continuous improvement
  • inspection readiness
  • CMO selection process
  • inclusion and belonging

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