Our client is seeking an experienced Director of Quality & Regulatory to lead all Quality Assurance and Regulatory Affairs activities across both the Canadian and U.S. operations. Reporting directly to the COO, this leadership role is responsible for developing and executing quality systems, ensuring regulatory compliance, managing supplier quality, and minimizing business risk. This is an excellent opportunity for a strategic, hands-on leader who thrives in a fast-paced, entrepreneurial environment. This position is fully remote.
What you will do in this role:
- Lead all Quality Assurance and Regulatory functions for food products, Natural Health Products (Canada), and dietary supplements (U.S.).
- Develop, implement, and maintain company-wide Quality Management Systems (QMS), including CAPA, change control, deviations, document control, supplier qualification, complaints, recalls, and product specifications.
- Ensure compliance with Canadian and U.S. regulatory requirements, including SFCR, FSMA, GMP, HACCP, and applicable food and nutraceutical regulations.
- Oversee regulatory records, product registrations, licenses, formulations, labeling, Certificates of Analysis (COAs), and technical documentation.
- Manage supplier qualification, approval, monitoring, and requalification programs using a risk-based approach.
- Lead customer, regulatory, certification, and third-party audits while ensuring audit readiness across the organization.
- Oversee complaint handling, adverse events, recalls, lot release, retention samples, and corrective and preventive actions.
- Support import compliance and ensure complete regulatory documentation for Canadian and U.S. operations.
- Partner with cross-functional teams including Operations, Purchasing, Product Development, Logistics, and Client Services to strengthen quality, compliance, and business continuity.
- Prepare executive-level reports, KPIs, compliance metrics, and risk assessments while supporting budgeting, forecasting, and business planning.
- Drive continuous improvement initiatives, ERP optimization, and process enhancements using Microsoft Dynamics 365 and Power BI.
What you will bring to the role:
- Bachelor’s degree in food science, Microbiology, Chemistry, Biochemistry, Nutrition, Pharmaceutical Sciences, or a related discipline (master’s degree is an asset).
- HACCP Certification required.
- PCQI certification strongly preferred.
- Lead Auditor certification (ISO 9001, FSSC 22000, or ISO 22000) is considered an asset.
- Minimum 10 years of progressive Quality and Regulatory leadership experience within food manufacturing, Natural Health Products, and dietary supplements across both Canada and the U.S.
- Proven experience managing outsourced manufacturing, supplier quality programs, regulatory inspections, customer audits, and third-party certification audits.
- Strong knowledge of SFCR, FSMA, GMP, HACCP, and other applicable food and nutraceutical regulations.
- Demonstrated experience implementing robust quality systems, including CAPA, Root Cause Analysis (RCA), Change Control, Risk Assessment, and continuous improvement programs.
- Solid understanding of food safety principles, food microbiology, allergen management, shelf-life validation, and stability programs.
- Experience supporting organizations with annual revenues between $50M and $500M and complex product portfolios.
- Strong leadership, organizational, analytical, and problem-solving skills with the ability to manage multiple priorities in a fast-paced environment.
What our client is offering:
- A competitive salary and full medical/health benefits for the employee and their family.
- The chance to join a growing company with a great work environment.
If you feel that this role would be a good fit for you, please submit your resume today in MS Word format – Don’t forget to include your accomplishments and achievements.
Pay: $140,000.00-$150,000.00 per year
Benefits:
- Dental care
- Extended health care
- Paid time off
- Work from home
Experience:
- Quality and Regulatory leadership : 10 years (preferred)
- Natural Health Products (Canada) : 10 years (preferred)
- Quality and Regulatory both Canada and the U.S: 10 years (preferred)
- dietary supplements (US): 10 years (preferred)
Licence/Certification:
- HACCP Certification (required)
- PCQI (preferred)
- Lead Auditor certification (preferred)
Work Location: Remote
