Director, Quality Assurance and Regulatory Affairs
Language: English, strong written and verbal communication required

About the Opportunity
This is an exciting prospect 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

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."

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📌 Director, Quality Assurance and Regulatory Affairs (Ontario)
🏢 Altis
📍 Ontario