Sterility Assurance Manager (12 Month Fixed Term Contract)

CSL Ltd

Liverpool, United Kingdom
**
5+ years gmp experience in pharmaceutical industry
Aseptic manufacturing or sterility assurance expertise
Risk-based decision making and quality risk management
** CSL Seqirus is seeking a Sterility Assurance Manager for a 12-month fixed-term contract in Liverpool, UK, to provide sterility assurance support and ensure compliance with manufacturing operations. The ideal candidate will have significant experience in GMP and aseptic manufacturing, with responsibilities including managing investigations, coaching staff, and contributing to regulatory inspections. **

Job Summary

  • This role provides critical sterility assurance support for Seqirus Liverpool and relevant CMO sites to ensure day-to-day operations meet validated status and Good Manufacturing Practice standards.
  • The successful candidate will act as a subject matter expert during regulatory inspections, manage complex deviation investigations, and lead necessary change management processes.
  • CSL Seqirus offers a collaborative culture focused on inclusion and belonging, supporting the development of a diverse workforce dedicated to global influenza prevention.

Matching Summary

Match Score: 75

** CSL Seqirus is seeking a Sterility Assurance Manager for a 12-month fixed-term contract in Liverpool, UK, to provide sterility assurance support and ensure compliance with manufacturing operations. The ideal candidate will have significant experience in GMP and aseptic manufacturing, with responsibilities including managing investigations, coaching staff, and contributing to regulatory inspections. **

Skills & Requirements

Must-have

  • 5+ years GMP experience in pharmaceutical industry
  • Aseptic manufacturing or sterility assurance expertise
  • Risk-based decision making and quality risk management
  • Product impact assessment authorisation capability
  • Regulatory inspection subject matter expert knowledge

Nice-to-have

  • Advanced degree in Microbiology or related field
  • Experience with closed system processing implementation
  • Ability to coach and develop specialist associates
  • Strong collaboration skills with engineering teams
  • Knowledge of global network harmonization processes

Key Requirements

  • Bachelor's degree in Microbiology, Biochemistry, or Pharmaceutical Sciences
  • Masters or PhD preferred
  • Must have 5+ years of GMP experience
  • Evidence of Risk Based Decision making experience

Work Rights

Not specified

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