Reporting to the Chief Innovation Officer, the Head of Quality Assurance oversees the Global Quality teams, provides strategic direction for product registrations and product entries in collaboration with the business and Global Quality teams. The ideal candidate is a seasoned people leader, able to foster a high-performance team by mentoring and developing management to ensure the group is well-equipped for scaling QA efforts. The ideal candidate has deep knowledge of GMP documentation requirements, understanding of the Canadian Cannabis Act and regulations, USA regulations, is highly organized, thinks strategically and creatively, adapts to changing priorities and demonstrates good communication, project management and problem-solving skills.
- Recruit and retain the Global Quality Assurance team by creating an environment that stimulates creativity, promotes their strengths, and supports their ongoing development.
- Work closely with the Quality Director and Managers to ensure that product manufacturing data generated for regulatory submissions comply with relevant jurisdiction-specific regulations and policies.
- Oversee the drafting, compiling, and controlling of product quality documentation to support Product Registration and Market Launch initiatives. Work cross-functionally with the business and Global Quality teams to ensure accurate communication occurs between all relevant internal stakeholders.
- Partners with Business Development, Global Quality and Regulatory teams to generate an up-to-date library of all documentation related to product quality.
- Establish and enforce GAP, GMP, GPP and quality assurance standards, providing technical and regulatory input for growing, packaging and production.
- Ensure compliance with Canadian and USA QA guidelines pertaining to business, production, facility, security, storage, packaging, labelling, import/export and distribution for the Cannabis program.
- Lead all key product quality issues such as complaint handling, recall coordination, investigations on deviations/failures and implementing corrective and preventive actions (CAPA), to close out quality and security gaps across all Canadian facilities.
- Oversee ERP System; Corrective Action and Preventative Action (CAPA) investigations.
- Act as the key point of contact for Health Agency auditors with inventory, sales and compliance audits.
- Ensures Quality System maintenance and management.
- Assess and stay up-to-date on regulatory requirements for CBD and THC products in both the Canadian and USA market; ensure Company product quality standards meet regulatory requirements in given market.
- Evaluate all feasible pathways for product registration via the applicable specific regulatory frameworks.
- Perform regular impact assessment reports of any regulatory changes to ensure continuous compliance with applicable regulations.
- Develop and maintain excellent relations with health regulatory agencies, including timely and professional communications.
- Provide GMP-related regulatory advice to QA-site heads and other departments (Facilities, Procurement, Manufacturing, Logistics, etc.) and advise on incorporating regulatory requirements into QMS documentation.
- M.Sc degree in a technical discipline (Food, Chemical or Biological Sciences preferred)
- 10+ years experience as a QA Leader in A GMP regulated environment; interacting with health regulatory agencies such as Health Canada, as well as having relevant US experience.
- Strong experience and knowledge of the food and supplement industry
- Experience implementing and maintaining quality management systems and programs (ISO9001, GMP for foods, drugs and cosmetics requirements)
- Strong understanding of regulatory requirements for international transfer of controlled substances
- Good Manufacturing Practice, HACCP, Food Safety, regulatory and environmental guidelines
- Experience in identifying GMP gaps with experience in writing SOPS, work instructions, HACCP plans, identifying GAPs, and with regulatory compliance and internal and external audits experience
- Consumer goods background strongly preferred
- Good understanding and knowledge of Regulatory Affairs and cGMPs
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