Global Sterility Assurance Director

GSK

Belgium
Aseptic or bioburden control manufacturing
Sterility assurance regulatory knowledge
Sterility assurance qms implementation
The Global Sterility Assurance Director is a pivotal role ensuring sterility assurance standards are understood and applied across GSK's vaccine and medicine manufacturing sites

Job Summary

  • The Global Sterility Assurance Director is a pivotal role ensuring sterility assurance standards are understood and applied across GSK's vaccine and medicine manufacturing sites.
  • This role involves partnering with R&D, MSAT, Quality, and Operations to ensure CMO adherence to stringent standards and identifying business solutions to enhance aseptic processes.
  • The Director plays a significant role in due diligence, serves as the person in plant, supports inspection readiness, resolves deviations, and leads remediation plans following regulatory observations.

Matching Summary

The Global Sterility Assurance Director is a pivotal role ensuring sterility assurance standards are understood and applied across GSK's vaccine and medicine manufacturing sites.

Skills & Requirements

Must-have

  • aseptic or bioburden control manufacturing
  • sterility assurance regulatory knowledge
  • sterility assurance QMS implementation
  • contract manufacturing organization (CMO) management
  • sterility assurance strategy development

Nice-to-have

  • influence leadership teams
  • personal credibility and confidence
  • network internally and externally
  • resilience and adaptability

Key Requirements

  • Bachelor degree in a Scientific Discipline
  • Significant experience in aseptic or bioburden control manufacturing
  • In depth knowledge of sterility assurance regulations and standards
  • Strong technical and quality skills in sterility assurance
  • Coaching and mentoring capabilities

Work Rights

Not specified

Tailored Resume

Cover Letter