Job Summary
Reporting to the Associate Director - Scientific Affairs, Quality and Risk Management, the Manager, Quality Systems is responsible for overseeing the development, validation, implementation, adoption, and maintenance of centralized Quality Systems across the division and proactively managing risk through the implementation of risk mitigation and minimization strategies.

Duties and Responsibilities

• Leads the development, validation, training, launch, and adoption of Centralized Quality Systems - Document Management System (DMS), Quality Management System (QMS), and Learning Management System (LMS) across the division.
• Manages Quality System enhancements, system change controls, validation, and roll-out to support evolving regulations and business needs.
• Oversees and reviews validation of new and existing computerized systems for compliance with company SOPs, 21 CFR Part 11, GAMP 5, and related regulatory requirements.
• Manages Quality Systems – DMS, QMS, and LMS operationally and ensures smooth operations.
• Leads and oversees the development of Operating Procedures (SOPs/WIs), Document Review and Approval Flow, Change Control Impact Assessment, and Training Assignment.
• Maintains the BSRx Quality Manual for procedural updates and audit readiness.
• Reviews and approves Quality Agreements with pharmaceutical clients and/or third-party subcontractors.
• Oversees Vendor Qualification and Requalification process, assesses the risk, and approves subcontractors from a quality standpoint.
• Leads audit readiness and supports internal and external audits/inspections – ISO and Pharma Manufacturer audits, Health Canada and College of Pharmacy inspections.
• Monitors ISO and Health Canada regulatory and quality requirements and proactively adapts the internal processes to meet the changing regulations.
• Risk Identification and Mitigation: Establishes a proactive approach to risk management. Identifies potential risks associated with our operating environment and related quality systems and mitigates/eliminates risk with innovative and cost-effective solutions.
• Develops and monitors quality metrics, including quality event trending, and presents data for management review for risk minimization strategies.
• Collaborates with internal and external teams in addressing quality events/deviations and identifies approaches to reduce/eliminate re-occurrence and associated risk with effective CAPA planning and implementation.
• Leads Quality 101 Education Sessions – Break silos and educate the teams to think of quality from the get-go and build quality into new systems and processes.