Senior Director, Regulatory & Quality

Description

• Ensure compliance with Health Canada (NNHPD, Cannabis Directorate), CFIA, and other applicable regulatory frameworks.
• Maintain up-to-date knowledge of evolving regulations and industry standards.
• Prepare for and lead internal audits, third-party certifications, and Health Canada/CFIA inspections.
• Serve as a subject matter expert on regulatory and quality matters for internal stakeholders.
• Identify and assess potential regulatory, quality, and safety risks.
• Advance efficiency, compliance maturity, and scalability across all QA/RA programs.
• Ensure regulatory and quality considerations are integrated throughout the product lifecycle.
• Oversee development and maintenance of SOPs for quality control, product testing, documentation, and manufacturing practices.
• Develop and communicate the organization’s regulatory and quality vision, strategy, and long-term goals.
• Lead investigations into quality issues, complaints, or non-conformances, ensuring root-cause analysis and corrective actions.
• Build, mentor, and lead high-performing teams across Regulatory Affairs, Quality Systems, and Quality Control.
• Lead regulatory inspections, correspondence, and responses.
• Ensure compliance with NHP regulations, cannabis regulations, SFCR, labelling requirements, and product standards.
• Oversee all regulatory submissions, licensing, and approvals related to NHPs, cannabis products, and food-related operations.
• Foster a culture of accountability, continuous learning, and operational excellence.
• Ensure effective deviation, CAPA, change control, internal audit, and risk-management processes.
• Partner with Operations, R&D, Product Development, Supply Chain, and Commercial teams to align on standards and ensure compliance throughout the product lifecycle.
• Ensure ongoing readiness and successful outcomes for site and system audits.
• Drive organizational improvements through data analysis, performance metrics, and structured quality initiatives.
• Design, implement, and maintain robust GMP, GPP, and HACCP-aligned quality programs across all sites.
• Provide strategic input to senior leadership on compliance matters, product planning, and business decisions.
• Support validation and qualification activities for equipment, facilities, and processes.
• Lead cross-functional efforts to support product claims, safety assessments, and technical documentation.

Requirements

• Demonstrated leadership experience in scaling teams and strengthening compliance programs across multiple sites.
• Proven success in managing regulatory submissions, licensing, inspections, and quality systems.
• Excellent communication, problem-solving, and stakeholder-management skills.
• Master’s degree in Food Science, Regulatory Affairs, Life Sciences, or related field (Bachelor’s degree considered with strong experience).
• Relevant certifications (e.g., HACCP, PCQI, RA/QA certifications) considered an asset.
• 10+ years of progressive experience in Regulatory Affairs and Quality roles within NHP, cannabis, food, pharma, or related regulated industries.
• Strong knowledge of Health Canada (NNHPD, Cannabis Regulations), CFIA, GMP, GPP, HACCP, and related frameworks.
• Must have authorization to work in Canada
• Travel Required
• Experience with crisis management, recalls, investigations, and compliance risk mitigation.

Benefits

• Retirement savings with employer matching
• Health, dental, and medical benefits
• Competitive wages
• Performance-based bonuses
• Strong growth and advancement opportunities
• Employee product purchase program

Training + Development

Interview process

Visa Sponsorship

Security clearance