Introduction

Senior Director, Quality Assurance and Regulatory Affairs

Toronto, ON

What are you going to do

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.

Essential skills and knowledge 

Requirements

  • Bachelor of Science (B.Sc.) or equivalent in a related field (e.g., Chemistry, Biology, or Chemical Engineering).
  • Minimum 15 years of experience in the GMP pharmaceutical industry with at least 5 years in senior Quality Assurance leadership.
  • Experience working with Health Canada and regulatory inspections.
  • Experience in Medical Devices; Supply Chain and Logistics background considered an asset.
  • Strong knowledge of GMP, GDP, and quality system management.
  • Advanced communication and interpersonal skills with the ability to influence across departments.
  • Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
  • Key Competencies
  • Strategic problem-solving and analytical decision-making.
  • Strong organizational and prioritization skills.
  • Ability to manage complexity and multiple stakeholders.
  • Excellent written and verbal communication skills in English; French considered an asset.

What we offer

What We Offer

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.

About Us

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.

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