The Senior Manager of Quality Assurance is a critical leadership role responsible for overseeing and advancing the company's Quality Management System (QMS) to ensure the highest standards of product quality, safety, and regulatory compliance.
Requirements
- Provide strategic leadership and oversight for the ongoing development, implementation, and maintenance of a robust and effective Quality Management System (QMS)
- Drive continuous improvement initiatives within the QMS, identifying and implementing best practices to optimize efficiency and effectiveness
- Ensure all QMS documentation (SOPs, policies, work instructions) is current, compliant, and effectively communicated across the organization
- Serve as a primary contact and subject matter expert during regulatory inspections (e.g., Health Canada)
- Maintain up-to-date knowledge of pharmaceutical regulations and industry standards, assessing their impact and ensuring proactive compliance
- Oversee and manage the timely review and release of finished pharmaceutical products
- Provide final approval for product disposition (release, quarantine, rejection)
- Lead the investigation and resolution of critical deviations, non-conformances, and out-of-specification (OOS) results
- Manage the change control process to ensure all proposed changes to processes, equipment, materials, or documentation are properly evaluated, approved, and implemented without compromising product quality or regulatory compliance
- Develop, implement, and manage the internal and external audit programs (e.g., supplier/vendor audits, contract manufacturer audits)
- Participate in the negotiation and maintenance of Quality Agreements with contract manufacturing organizations (CMOs), contract testing laboratories, and other critical suppliers
- Champion quality risk management principles, integrating risk-based decision-making into all QA activities and QMS processes
- Promote and ensure adherence to data integrity principles throughout all quality-related activities and systems
- Ensure the development and delivery of effective GMP and QMS training programs for relevant personnel across the organization
- Lead, mentor, and develop a team of Quality Assurance professionals, fostering a culture of quality, accountability, and continuous improvement
Benefits
- Purchase discount program
- Competitive pay
- Online learning through Academy
