About the RoleWe are seeking an experienced, strategic, and hands-on Vice President, Quality & Regulatory Affairs to lead the company's quality, compliance, and regulatory functions across Canada, the United States, and international markets.
As a key member of the leadership team, the VP will be responsible for ensuring the highest standards of product quality, safety, regulatory compliance, and operational excellence throughout the product lifecycle. This role will oversee Quality Assurance, Quality Control, Regulatory Affairs, supplier quality management, and regulatory risk mitigation while enabling innovation and supporting the company's growth objectives.
The ideal candidate combines deep regulatory expertise in Natural Health Products (NHPs), dietary supplements, functional foods, and consumer health products with a proven track record of building high-performing teams, developing scalable quality systems, and successfully navigating complex domestic and global regulatory environments.
Key Responsibilities- Quality Strategy & Governance
- Develop and execute the company's quality strategy, ensuring alignment with business objectives and regulatory requirements.
- Establish and maintain robust Quality Management Systems (QMS) that support scalable growth, operational excellence, and compliance.
- Lead QA/QC efforts across internal functions, contract manufacturers, laboratories, suppliers, and external partners.
- Ensure rigorous quality standards are maintained across sourcing, manufacturing, testing, packaging, distribution, and post-market activities.
- Foster a company-wide culture of quality, accountability, and continuous improvement.
- Regulatory Affairs & Compliance
- Develop and lead the global regulatory strategy for all product categories, including Natural Health Products, dietary supplements, OTC products, functional foods, and cosmetics.
- Ensure compliance with applicable Health Canada, FDA, CFIA, FTC, and relevant international regulations.
- Oversee all product registrations, licensing activities, submissions, amendments, renewals, and regulatory correspondence.
- Interpret emerging regulatory requirements and proactively assess business impacts and compliance risks.
- Serve as the primary liaison with regulatory agencies and industry associations.
- Ensure product claims and marketing communications remain scientifically substantiated and compliant.
- Supplier & External Partner Management
- Establish quality expectations, performance metrics, and service-level agreements for contract manufacturers, testing laboratories, and strategic suppliers.
- Lead supplier qualification, audit, and performance management programs.
- Identify and address quality or compliance issues before they impact customers, products, or business operations.
- Build strong partnerships with external stakeholders that support long-term quality and regulatory objectives.
- Risk Management & Audit Readiness
- Lead company-wide compliance and risk management initiatives.
- Ensure inspection and audit readiness across all facilities, suppliers, and third-party partners.
- Oversee investigations, CAPA programs, deviations, complaints, recalls, and non-conformance management.
- Identify emerging regulatory, quality, and operational risks and develop mitigation strategies.
- Drive continuous improvement of SOPs, compliance processes, and training programs.
- Leadership & Team Development
- Build, mentor, and develop a high-performing Quality and Regulatory organization.
- Create clear performance expectations, development plans, and succession strategies.
- Promote cross-functional collaboration across Product Development, Marketing, Operations, Supply Chain, and Finance.
- Serve as a trusted advisor to the Executive Leadership Team on quality, compliance, and regulatory matters.
- Provide executive-level reporting and recommendations related to quality performance, regulatory risks, and compliance initiatives.
- Systems, Data & Continuous Improvement
- Lead implementation and optimization of systems, dashboards, and reporting tools to improve visibility and decision-making.
- Leverage data analytics and KPI reporting to identify trends, improve efficiencies, and strengthen compliance performance.
- Support process automation and digital transformation initiatives across Quality and Regulatory functions.
- Champion continuous improvement initiatives that increase speed, scalability, and operational effectiveness.
- Perform other duties and special projects as assigned.
Skills & Competencies Required- Bachelor's degree in Life Sciences, Regulatory Affairs, Pharmacy, Food Science, Chemistry, Microbiology, or a related discipline.
- Advanced degree or Regulatory Affairs Certification (RAC) considered an asset.
- 12+ years of progressive leadership experience in Quality Assurance, Quality Control, Regulatory Affairs, or related disciplines.
- 5+ years in senior leadership roles managing multi-functional teams.
- Demonstrated experience within Natural Health Products, dietary supplements, consumer health, food, pharmaceutical, wellness, or adjacent regulated industries.
- Extensive knowledge of Health Canada NHP Regulations, FDA frameworks, CFIA requirements, GMPs, and international regulatory requirements.
- Experience leading regulatory submissions, inspections, audits, licensing activities, and market entry initiatives.
- Proven success building scalable quality systems and compliance programs in a high-growth environment.
- Experience managing external manufacturers, suppliers, laboratories, and quality partners.
Apply Now Please submit your resume and short note about why you are excited about this opportunity and joining Organika! While we may not be able to respond to everyone individually, please know that we truly appreciate the time and effort you put into your application, and we will be in touch with only those successfully selected for next steps.
