Director of Quality Assurance - Sterile Manufacturing

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