Global Sterility Assurance Systems & Standards Specialist

cslseqirus.co.nz

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Sterility assurance standards
Microbial contamination control strategy
Regulatory and csl standards adherence
** CSL Seqirus is seeking a Global Sterility Assurance Systems & Standards Specialist who will lead sterility assurance efforts within the pharmaceutical manufacturing sector. The role involves strategic leadership in sterility assurance standards, collaboration with global teams, and ensuring compliance with regulatory requirements. **

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

Match Score: 75

** CSL Seqirus is seeking a Global Sterility Assurance Systems & Standards Specialist who will lead sterility assurance efforts within the pharmaceutical manufacturing sector. The role involves strategic leadership in sterility assurance standards, collaboration with global teams, and ensuring compliance with regulatory requirements. **

Skills & Requirements

Must-have

  • Sterility assurance standards
  • Microbial contamination control strategy
  • Regulatory and CSL standards adherence
  • Sterile filtration, aseptic filling, lyophilization
  • Inspection readiness for sites
  • CMO and filling strategies support

Nice-to-have

  • Strategic leadership
  • Continuous improvement
  • Holistic approach
  • Proactive role
  • 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 and other regulatory agency guidelines
  • Interacting with regulatory authorities

Work Rights

Not specified

Tailored Resume

Cover Letter