Quality Assurance (QA) Manager – GMP Facility

Oakville, Ontario, Canada
Full-time, Monday to Friday

GL CHEMTEC INTERNATIONAL is a leading Contract Research and Manufacturing Organization specializing in advanced pharmaceutical materials (APIs), polymers, and drug delivery technologies. We are ISO 9001 and ISO 13485 certified and have recently expanded our operations with a state-of-the-art GMP facility.

We are seeking an experienced Quality Assurance (QA) Manager to lead and oversee all quality operations within our GMP environment. This is a key leadership role ensuring compliance with GMP, ISO standards, and regulatory expectations while supporting our mission to deliver innovation and excellence to our global clients.

Key responsibilities:

• Establish, implement, and maintain QA systems in compliance with GMP, ISO 9001, and ISO 13485 standards.
• Lead audits, inspections, and regulatory submissions, ensuring full compliance with Health Canada, FDA, and international requirements.
• Develop, approve, and oversee SOPs, quality manuals, and documentation control systems.
• Manage deviation, CAPA, change control, and risk management processes.
• Train and mentor staff in GMP compliance and quality best practices.
• Collaborate with R&D, manufacturing, and senior leadership to support continuous improvement and operational excellence.

Qualifications:

• Bachelor’s degree in Chemistry, Life Sciences, or a related field (advanced degree preferred).
• Minimum 5–7 years of QA experience in a GMP-regulated environment, with proven management or supervisory experience.
• Strong knowledge of GMP, ISO 9001, ISO 13485, and relevant regulatory guidelines.
• Experience with audits (internal and external) and regulatory inspections.
• Excellent leadership, communication, and organizational skills.

Why Join GL CHEMTEC?

• Opportunity to shape and lead QA within a new GMP facility.
• Collaborative, science-driven culture with focus on innovation.
• Competitive compensation and benefits.
• Strong long-term growth potential in a dynamic organization.

If you are a quality-focused leader with GMP experience and a passion for excellence, we invite you to apply and be part of our growth journey.

Please submit your application via LinkedIn or directly to info@glchemtec.ca