Global Sterility Assurance Director

GlaxoSmithKline (GSK)

Belgium
Sterility assurance standards
Aseptic and low bioburden manufacturing
Quality management system (qms)
The Global Sterility Assurance Director is a pivotal role within the Strategic Product Quality staff, bringing critical expertise in sterility assurance across various initiatives and projects within GSK's internal and external commercial and R&D vaccine and medicine drug substance and drug product manufacturing sites

Job Summary

  • The Global Sterility Assurance Director is a pivotal role within the Strategic Product Quality staff, bringing critical expertise in sterility assurance across various initiatives and projects within GSK's internal and external commercial and R&D vaccine and medicine drug substance and drug product manufacturing sites.
  • A key responsibility of the Global Sterility Assurance Director is to partner with various teams, including those in Research & Development (R&D), Materials, Science & Technology (MSAT), Quality, and Operations, to ensure that contract manufacturing organizations (CMOs) adhere to these stringent standards.
  • The Director is also involved in resolving ongoing incidents and deviations, and plays a central role in remediation plans following any regulatory observations, making it a highly strategic and impactful position within the organization.

Matching Summary

The Global Sterility Assurance Director is a pivotal role within the Strategic Product Quality staff, bringing critical expertise in sterility assurance across various initiatives and projects within GSK's internal and external commercial and R&D vaccine and medicine drug substance and drug product manufacturing sites.

Skills & Requirements

Must-have

  • sterility assurance standards
  • aseptic and low bioburden manufacturing
  • Quality Management System (QMS)
  • regulatory agencies
  • contamination control strategy

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 regulations and industry standards
  • Strong technical and quality skills
  • Coaching and mentoring capabilities

Work Rights

Not specified

Tailored Resume

Cover Letter