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Director of Quality Assurance - Sterile Manufacturing

Posted on: 12 Jan
clock Full time
location Canada (On-Site)


Key Responsibilities:

  • Lead and oversee all Quality Assurance activities for sterile manufacturing operations
  • Ensure compliance with GMP requirements (Health Canada, FDA, EMA, ICH)
  • Own quality systems including deviations, CAPA, change control, and batch release
  • Lead regulatory inspections, client audits, and ensure continuous inspection readiness
  • Partner cross-functionally with manufacturing, validation, and technical teams
  • Support technology transfer and new product introductions
  • Build, mentor, and develop a high-performing QA team


Qualifications & Experience:

  • 10+ years of Quality Assurance experience in a sterile CDMO/CMO environment
  • Strong hands-on expertise in aseptic processing and sterile manufacturing
  • Proven experience leading regulatory inspections and audits
  • Solid understanding of global GMP requirements
  • Strong leadership, communication, and decision-making skills
  • Bachelor’s degree in a scientific discipline (advanced degree a plus)


What We Offer:

  1. Leadership role at a modern, state-of-the-art sterile manufacturing site in Canada
  2. Competitive compensation and benefits
  3. Opportunity to make a direct impact on quality strategy and operational excellence
  4. Collaborative, growth-focused CDMO environment

To enquire after more details for this position email Tom Acomb on tacomb@44international.com or call on +44 20 3838 2494.
Or, use the button below to apply online:

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