Director, Quality Assurance and Regulatory Affairs

Altis Technology; Mississauga; Hybrid; CAD 121,000 - 151,000; Full time

Benefits offered by this job

Health & Dental benefits

Retirement savings

Tuition reimbursement

Training & career development

Job summary

Altis Technology is seeking an accomplished Director to lead Quality Assurance and Regulatory Affairs in a hybrid Mississauga setting. This role shapes compliance programs, quality systems, and continuous improvement across a national operation serving healthcare clients.

You will partner with senior leaders to balance patient safety, service excellence, and regulatory adherence, while building high-performing teams and advancing a mature QMS/eQMS culture across sites.

Qualifications

• 15+ years of QA and/or Regulatory Affairs experience in pharma, healthcare, or medical devices.
• 6+ years of leadership experience managing multi-site teams and senior leaders.
• 5+ years in regulated healthcare 3PL distribution or wholesale warehouse environments.
• Strong knowledge of Health Canada regulations, GxP, GMP, GDP, ISO, DEL/MDEL licensing, and controlled substances compliance.
• Experience with QMS/eQMS, CAPA, validation, cold chain compliance, WMS, and CSV.
• Proven ability to partner effectively with operations, customers, and senior leadership.

Responsibilities

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

Skills

Leadership

Regulatory knowledge

Quality culture

Risk-based mindset

Education

Master of Science

Tools

QMS/eQMS

CAPA

CSV

WMS

GxP standards

Job description

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, youll help ensure products are stored and distributed safely, efficiently, and in accordance with Canadian regulatory requirements.

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

Whats In It for You

Join a collaborative organization where quality is viewed as a strategic business partner. Youll 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

• Youll lead and continuously improve the QMS/eQMS across multiple sites, ensuring compliance with GMP, GDP, ISO standards, DEL/MDEL requirements, and controlled substances regulations.
• Youll oversee key quality processes including CAPA, deviations, change control, vendor qualification, document management, product release, complaints, recalls, returns, and destruction.
• Youll lead internal, customer, and regulatory audits, including remediation and ongoing compliance readiness.
• Youll oversee CSV, WMS compliance, facility and equipment qualification, temperature mapping, environmental monitoring, cold chain processes, excursion management, and packaging qualification.
• Youll partner with operations and commercial teams on risk-based decisions, customer implementations, RFPs, solution design, Quality Agreements, and business reviews.
• Youll 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

Were looking for a quality leader who understands that strong compliance and strong operations go hand in hand. Youll bring sound judgment, a practical risk-based mindset, and the leadership skills to build trust across teams while continuing to strengthen our quality culture.

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.