Senior Director, Quality Assurance and Regulatory Affairs

Job Description

<p><b>Senior Director, Quality Assurance and Regulatory Affairs</b></p><p><b>Toronto, ON</b></p><p><br></p><p><b>Introduction</b></p><p>Brunel is partnering with a leading Canadian retail pharmacy network to support the search for a Senior Director, Quality Assurance. This role will provide leadership and oversight of Quality and Regulatory functions across multiple business units within a national healthcare organization. The successful candidate will be responsible for maintaining compliance with Health Canada regulations and ensuring effective implementation of Quality Management Systems across licensed facilities and distribution channels.</p><p><br></p><p>Reporting directly to the Vice President, Pharmaceutical Sourcing and Commercial Operations, the Senior Director, Quality Assurance will oversee the design, implementation, and continuous improvement of quality and regulatory programs. This position requires advanced leadership, sound regulatory knowledge, and the ability to drive compliance in a complex, multi-site environment.</p><p><br></p><p><b>Responsibilities</b></p><p>Quality Management Systems</p><ul><li>Establish, implement, and maintain Quality Management Systems (QMS) and Risk Management Programs in accordance with Health Canada regulations.</li><li>Develop and update Standard Operating Procedures (SOPs).</li><li>Oversee Health Canada inspections and manage all required regulatory licenses (e.g., DEL, MDEL, NBCP Wholesale License).</li><li>Ensure compliance across all Health Product licensed facilities and the Import Drug Products QMS.</li><li>Oversee the Computerized System Validation process and the QMS for the organization's e-commerce platform.</li></ul><p>Regulatory Oversight</p><ul><li>Manage SAP Master Data for pharmacy schedules, drugs, medical devices, and natural health product attributes.</li><li>Lead third-party audits and perform vendor qualification assessments, including Quality Agreements.</li><li>Conduct internal GMP self-inspections and report on findings to ensure ongoing compliance.</li><li>Oversee the Product Quality Complaint Program.</li><li>Provide quality and regulatory oversight for multiple business units, including Shoppers Drug Mart, MediSystem Pharmacy, Central Pharmacy Services, Sanis Inc., and Specialty Health Network.</li></ul><p>Leadership and Collaboration</p><ul><li>Lead, mentor, and develop quality teams across multiple locations.</li><li>Collaborate cross-functionally with operations, supply chain, and senior leadership to support business objectives.</li><li>Ensure alignment with corporate compliance and regulatory expectations.</li><li>Occasional travel to national sites as required.</li></ul><p><br></p><p><b>Requirements</b></p><ul><li>Bachelor of Science (B.Sc.) or equivalent in a related field (e.g., Chemistry, Biology, or Chemical Engineering).</li><li>Minimum 15 years of experience in the GMP pharmaceutical industry with at least 5 years in senior Quality Assurance leadership.</li><li>Experience working with Health Canada and regulatory inspections.</li><li>Experience in Medical Devices; Supply Chain and Logistics background considered an asset.</li><li>Strong knowledge of GMP, GDP, and quality system management.</li><li>Advanced communication and interpersonal skills with the ability to influence across departments.</li><li>Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).</li><li>Key Competencies</li><li>Strategic problem-solving and analytical decision-making.</li><li>Strong organizational and prioritization skills.</li><li>Ability to manage complexity and multiple stakeholders.</li><li>Excellent written and verbal communication skills in English; French considered an asset.</li></ul><p><br></p><p><b>What We Offer</b></p><p>Why apply through Brunel? Finding the next step in your career can be a fulltime job in itself. We manage the process for you: from submitting your resume to coordinating interviews to extending offers and assisting with on-boarding. We'll get you going while you get on with the job.</p><p><br></p><p><b>About Us</b></p><p>Brunel has a reputation for working with some of the best in the business. That's what we continually strive for. Over 45 years, we've created a global network of interesting clients and talented individuals working together through a vast array of services.</p>