Quality Systems Specialist

Apply quality systems expertise at Novocol Pharma in Cambridge, Ontario, using GMP knowledge and continuous improvement skills. Work closely with manufacturing teams.

The Quality Systems & Continuous Improvement Specialist provides quality and compliance leadership within cross-functional initiatives. The position partners with Production, Engineering, Technical Services, Validation, and Quality personnel. It supports manufacturing performance, product quality, and quality system effectiveness through investigations, risk assessments, CAPAs, and sustainable process improvements.

• Provide GMP and regulatory guidance to cross-functional improvement initiatives
• Lead investigations involving deviations, complaints, audits, and quality events
• Develop, implement, verify, and close CAPAs on time
• Assess changes affecting processes, equipment, facilities, and procedures
• Monitor quality data, metrics, risks, and recurring issues

• Bachelor’s degree in engineering, life science, physical science, or related field
• At least five years in GMP-regulated manufacturing
• Experience leading investigations, CAPAs, and continuous improvement initiatives
• Strong knowledge of GMP regulations, quality systems, and risk management
• Knowledge of Health Canada, FDA, EU GMP, and industry standards

Bring quality systems leadership, root cause analysis, and risk-based decision-making to Novocol Pharma’s Cambridge manufacturing operations.