16 Sep
|
Emerald Lane Recruitment
|
Greater Toronto Area
16 Sep
Emerald Lane Recruitment
Greater Toronto Area
Director, Quality & Regulatory
Full-Time, Onsite
Western GTA, Ontario
Our client is a licensed Canadian (LP) cannabis manufacturer producing products for the domestic market.
They are seeking a Director, Quality & Regulatory with a minimum of 8 to 10 years of progressive quality and regulatory experience within highly regulated manufacturing, including at least 3 years leading quality organizations and direct experience leading Health Canada inspections.
Reporting to the CEO, this role owns the quality and regulatory strategy, the Quality Management System, and the Quality & Regulatory team. It is a hands-on, onsite leadership role in a production environment, and is not a standard 9:00 a.m. to 5:00 p.m. position.
Must-Have Requirements
- Must have a minimum of 8 to 10 years of progressive quality and regulatory experience within highly regulated manufacturing environments.
- Must have a minimum of 3 years leading quality organizations.
- Must have demonstrated experience building and scaling Quality Management Systems within growing manufacturing businesses.
- Must have experience leading Health Canada inspections and regulatory interactions.
- Must have strong working knowledge of the Cannabis Act, Cannabis Regulations, Good Production Practices (GPP) and Good Manufacturing Practices (GMP).
- Must have a bachelor's degree in science, engineering, pharmacy, microbiology, regulatory affairs, quality assurance, or a related discipline.
- Must work onsite in the Western GTA, Ontario, and be present and visible in the facility with the team.
- Must be comfortable working outside a standard 9:00 a.m. to 5:00 p.m. schedule to support production coverage, including occasional Saturdays.
- Must be legally authorized to work in Canada.
Key Responsibilities
Strategic Leadership
- Develop and execute the long-term Quality & Regulatory strategy aligned with business growth objectives.
- Serve as the executive owner of the Quality Management System (QMS), ensuring it remains scalable as the organization expands.
- Build organizational capability by developing high-performing quality and regulatory teams.
- Establish KPIs, dashboards and reporting systems that provide executive visibility into quality performance and compliance risk.
- Champion a culture of quality, accountability and continuous improvement across all departments.
- Partner with executive leadership on strategic initiatives, capital investments, acquisitions, new product launches and facility expansion.
Regulatory Strategy & Compliance
- Provide executive oversight of all Health Canada licensing activities, regulatory submissions, amendments and compliance programs.
- Serve as the senior company representative during Health Canada inspections and other regulatory audits.
- Develop proactive regulatory strategies that anticipate legislative changes and evolving industry requirements.
- Lead regulatory readiness initiatives for future certifications and international market expansion, including GMP and EU GMP where applicable.
- Maintain oversight of all regulatory documentation, SOP governance, record retention and compliance systems.
Quality Systems Leadership
- Own and continuously improve the Quality Management System.
- Ensure robust systems for SOP management, change control, deviations, CAPA, risk assessments, internal audits, supplier qualification, validation, document control and product release.
- Drive implementation of electronic quality systems and digital transformation initiatives where appropriate.
- Ensure quality systems support operational excellence while maintaining regulatory compliance.
Operational Excellence
- Partner with operations, manufacturing, supply chain, procurement, R&D;, commercial and finance to embed quality into every stage of the product lifecycle.
- Establish risk-based quality systems that improve efficiency while maintaining product safety and compliance.
- Lead cross-functional investigations involving major deviations, recalls, complaints and critical quality events.
- Oversee supplier quality programs and vendor qualification processes.
- Drive continuous improvement initiatives using Lean, Six Sigma and risk-based methodologies.
Leadership & People Development
- Lead, mentor and develop the Quality & Regulatory organization.
- Provide coaching and succession planning for the Manager of Quality & Regulatory and other team members.
- Establish departmental objectives, performance metrics and development plans.
- Promote cross-functional collaboration and strengthen quality ownership across the organization.
- Develop company-wide quality and compliance training strategies.
Governance & Risk Management
- Lead enterprise quality risk management activities.
- Report quality performance, regulatory status and compliance risks to the executive leadership team.
- Develop contingency plans for significant quality events and regulatory risks.
- Ensure effective management of product complaints, recalls, investigations and corrective actions.
- Maintain inspection readiness at all times.
Experience & Skill Requirements Essential
- A minimum of 8 to 10 years of progressive quality and regulatory experience within highly regulated manufacturing environments.
- A minimum of 3 years leading quality organizations.
- Demonstrated experience building and scaling Quality Management Systems in growing manufacturing businesses.
- Experience leading Health Canada inspections and regulatory interactions.
- Robust knowledge of the Cannabis Act, Cannabis Regulations, Good Production Practices, Good Manufacturing Practices, HACCP, CAPA systems, change control, validation and supplier quality.
- A bachelor's degree in science, engineering, pharmacy, microbiology, regulatory affairs, quality assurance or a related discipline.
- Proven ability to build high-performing teams and influence organizational culture.
- Strong executive presence, with exceptional communication and stakeholder management skills.
Desirable
- Knowledge of EU GMP and experience preparing a business for international market expansion.
- Professional certifications such as ASQ, CQE, CQA, RAC or Lean Six Sigma Black Belt.
- Experience supporting ERP implementation and quality system digitization.
- A master's degree in a related discipline.
What They Offer
- Comprehensive health and wellness benefits, effective from day one.
- Discretionary bonus based on individual and company performance against KPIs.
- Employee stock option and Employee Ownership Trust (EOT) program.
- Approximately 15 to 20 vacation days, with flexibility at senior levels.
Location & Schedule: Onsite in the Western GTA, Ontario. The facility operates Monday to Friday with extended production hours, and occasional Saturday flexibility may be required.
Compensation: In compliance with Ontario pay transparency legislation, the expected salary range for this role is $85,000 to $110,000 annually, plus a discretionary bonus.
Accessibility: Accommodation is available throughout the recruitment process in accordance with the Accessibility for Ontarians with Disabilities Act (AODA). Applicants requiring accommodation are encouraged to advise during the application process.
Vacancy Disclosure: This job posting is for an existing vacancy.
AI Disclosure: At Emerald Lane Recruitment, we do not use artificial intelligence (AI) tools to screen, assess, or select applicants as part of the hiring process. AI tools are used by our back office to support efficiency, but humans review, assess, and decide throughout the hiring process.
Equal Opportunity Statement
Emerald Lane Recruitment is committed to advancing equity and inclusion across the global cannabis industry. We proudly support our clients in building teams that reflect the full diversity of the communities they serve. All qualified applicants will receive consideration for employment without regard to any protected characteristic, in accordance with applicable human rights legislation.
📌 Director Quality Assurance Regulatory Affairs (Greater Toronto Area)
🏢 Emerald Lane Recruitment
📍 Greater Toronto Area