Director, Quality Assurance and Regulatory Affairs

Director, Quality Assurance and Regulatory Affairs
Location: Mississauga, ON, Hybrid
Language: English, strong written and verbal communication required

About the Opportunity
This is an exciting opportunity for an experienced quality and regulatory leader to shape compliance, quality systems, and continuous improvement within a highly regulated healthcare logistics environment. Working at the intersection of quality, operations, and customer experience, you’ll help ensure products are stored and distributed safely, efficiently, and in accordance with Canadian regulatory requirements.

As Director, Quality Assurance and Regulatory Affairs, you’ll serve as a trusted advisor to senior leaders, operational teams, and customers. You’ll lead a national quality function, strengthen quality culture, and apply a pragmatic, risk-based approach that balances compliance, service excellence, and patient safety.

What’s In It for You
Join a collaborative organization where quality is viewed as a strategic business partner. You’ll have the opportunity to influence national quality strategy, develop high-performing teams, and contribute to continuous improvement across a complex healthcare logistics network. This permanent opportunity offers a salary range of $120,934 to $151,167, plus health and dental benefits, retirement savings, tuition reimbursement, training, and career development opportunities.

Your Responsibilities
• You’ll lead and continuously improve the QMS/eQMS across multiple sites, ensuring compliance with GMP, GDP, ISO standards, DEL/MDEL requirements, and controlled substances regulations.
• You’ll oversee key quality processes including CAPA, deviations, change control, vendor qualification, document management, product release, complaints, recalls, returns, and destruction.
• You’ll lead internal, customer, and regulatory audits, including remediation and ongoing compliance readiness.
• You’ll oversee CSV, WMS compliance, facility and equipment qualification, temperature mapping, environmental monitoring, cold chain processes, excursion management, and packaging qualification.
• You’ll partner with operations and commercial teams on risk-based decisions, customer implementations, RFPs, solution design, Quality Agreements, and business reviews.
• You’ll lead and develop a national quality team while establishing KPIs, executive reporting, accountability, and continuous improvement through Lean and Six Sigma principles.

Skills and Qualifications
• Masters of Science
• Experience working with narcotics and substance control
• 15+ years of Quality Assurance and/or Regulatory Affairs experience within pharmaceutical, healthcare, or medical device environments.
• 6+ years of leadership experience managing multi-site teams and senior leaders.
• 5+ years of experience within regulated healthcare 3PL distribution or wholesale warehouse environments.
• Strong knowledge of Health Canada regulations, GxP standards, GMP, GDP, ISO requirements, DEL/MDEL licensing, and controlled substances compliance.
• Demonstrated experience with QMS/eQMS, CAPA, validation, cold chain compliance, WMS, and Computer System Validation (CSV).
• Proven ability to partner effectively with operations, customers, commercial teams, and senior leadership.

Note from the Hiring Manager
“We’re looking for a quality leader who understands that strong compliance and strong operations go hand in hand. You’ll bring sound judgment, a practical risk-based mindset, and the leadership skills to build trust across teams while continuing to strengthen our quality culture.”

Why Partner with Altis
If you’ve never worked with a staffing agency before, we make it easy. We work with top employers across Canada who have great jobs to fill, each vetted and verified by our team. When you apply for a job with Altis, we get to know you as a candidate and learn what your strengths are. Then, if you’re a solid match, we handle all the logistics, advocating for you as a candidate for the role, providing access to coaching and connecting you directly with the hiring manager. And rest assured, all our services are free of cost for candidates.

We appreciate the time and effort all applicants invest in their submissions. Please note that only candidates shortlisted for this role will be contacted directly. However, your profile will remain under consideration for future opportunities that align with your experience and career goals.All qualified applicants will receive fair consideration for employment. We welcome individuals of all backgrounds, experiences, and identities including those who identify as women, members of racialized groups, Indigenous Peoples, persons with disabilities, and 2SLGBTQIA+ communities. If you require an accommodation, please review our accessibility policy and reach out to our accessibility officer with any questions. Our human recruiters review all applications and always make the final hiring decision. On occasion, we also use AI-assisted tools to help review applications.