Senior Director, Quality Assurance and Regulatory Affairs

Responsibilities

Quality Management Systems

• Establish, implement, and maintain Quality Management Systems (QMS) and Risk Management Programs in accordance with Health Canada regulations.
• Develop and update Standard Operating Procedures (SOPs).
• Oversee Health Canada inspections and manage all required regulatory licenses (e.g., DEL, MDEL, NBCP Wholesale License).
• Ensure compliance across all Health Product licensed facilities and the Import Drug Products QMS.
• Oversee the Computerized System Validation process and the QMS for the organization's e-commerce platform.

Regulatory Oversight

• Manage SAP Master Data for pharmacy schedules, drugs, medical devices, and natural health product attributes.
• Lead third-party audits and perform vendor qualification assessments, including Quality Agreements.
• Conduct internal GMP self-inspections and report on findings to ensure ongoing compliance.
• Oversee the Product Quality Complaint Program.
• Provide quality and regulatory oversight for multiple business units, including Shoppers Drug Mart, MediSystem Pharmacy, Central Pharmacy Services, Sanis Inc., and Specialty Health Network.

Leadership and Collaboration

• Lead, mentor, and develop quality teams across multiple locations.
• Collaborate cross-functionally with operations, supply chain, and senior leadership to support business objectives.
• Ensure alignment with corporate compliance and regulatory expectations.
• Occasional travel to national sites as required.