Quality Sterility Assurance & Microbiology Manager

Sanofi

Le Trait, France
Sterility assurance strategy
Microbiology programs
Gmp compliance
Define and drive our sterility assurance strategy, lead a team of dedicated experts, and be a key partner in our continuous improvement journey

Job Summary

  • Define and drive our sterility assurance strategy, lead a team of dedicated experts, and be a key partner in our continuous improvement journey.
  • Design and drive sterility assurance and microbiology programs, ensuring full compliance with regulatory requirements (GMP, Annex 1, FDA, Pharmacopoeia) and company quality standards.
  • Lead, coach, and develop a team of experts, fostering a strong culture of quality and operational excellence with regular field presence (~25% of time).

Matching Summary

Define and drive our sterility assurance strategy, lead a team of dedicated experts, and be a key partner in our continuous improvement journey.

Skills & Requirements

Must-have

  • Sterility assurance strategy
  • Microbiology programs
  • GMP compliance
  • Annex 1, FDA, Pharmacopoeia
  • Aseptic processing
  • Environmental monitoring
  • Risk management

Nice-to-have

  • Continuous improvement initiatives
  • AI and automation
  • Patient safety focus
  • Cross-functional collaboration

Key Requirements

  • Significant experience in sterility assurance
  • Microbiological control experience
  • Management of compliance
  • Health authority relations experience
  • B2 English level

Work Rights

Not specified

Tailored Resume

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