Vice President Quality Assurance And Regulatory Affairs / Quality Assurance Person (Qap)
Positions Held at Nextleaf Labs Ltd: President (06/2018-07/2020), Responsible Person (09/2019-05/2021), Vice-President Quality Assurance and Regulatory Affairs (12/2020-02/2022), Quality Assurance Person (09/2019-03/2022), Alternate Quality Assurance Person (03/2022-09/2023), Director of Regulatory Affairs (02/2022-09/2022), Director of Scientific and Technical Affairs (09/2022-03/2023)• Founded Nextleaf Labs, a federally-licenced cannabis company specializing in large-scale alcohol-based extraction and refinement of pure intermediates and subsequent formulation into finished products• Oversaw initial Health Canada licence applications, including subsequent sales licence amendments; ongoing licence management• Instrumentally involved in facility design and construction, including physical security requirements and drafting and maintenance of Physical and Organizational Security Plan• Devised, executed, and managed the Quality Management System (QMS), including the drafting, review, and approval of more than 75 SOPs• Reviewed and approved of more than 200 batch records, from procurement to final batch release• Collaborated with Production and Marketing departments to commercialize more than a dozen products• Oversaw and directed the laboratory and retention sample program, including review of laboratory results (Certificates of Analysis, CoAs), Out-of-Specification (OOS) investigations including Root Cause Analysis (RCA), and mandated pesticide reporting• Implemented Change Control, Deviation, Recall, and Complaint Management programs• Led regulatory (Health Canada, Canada Revenue Agency), internal, and external audits and inspections• Performed monthly reconciliation of inventory; submission of reports to Health Canada (CTLS) and the Canada Revenue Agency• Provided regular advice, guidance, and risk assessments to management and stakeholders on various regulatory, scientific, and technical issues
