Head of Quality Assurance & Regulatory Compliance

Job description

Numinus is on a mission to help people heal and be well. The costs of mental illness, addiction and trauma are too high - that’s why we’re developing new treatments and approaches that use rigorous, up-to-date research and methodologies to support solutions for healing. We are a public company listed on the TSX Venture Exchange under the symbol $NUMI.


Based out of our Nanaimo office on beautiful Vancouver Island and reporting to the Chief Operating Officer, this full-time position with Numinus Bioscience is a unique opportunity to join the early stages of an integrated company on a high-growth trajectory and solid operational foundation, from our involvement in the dynamic psychedelic therapy space to our revenue-supporting cannabis operations.


The Head of QA & Regulatory Compliance is a leadership role that will be expected to provide subject-matter direction and guidance in a fast-paced and rapidly evolving environment. The role spans all business areas: laboratory operations (Health Canada Cannabis Testing License and Office of Controlled Substances Dealers License), cannabis production (late-stage applicant for a Standard Processor License entering the request-for-information stage) and helping inform clinic operations that will span North America, and psychedelic-assisted therapy R&D efforts.



WHAT YOU’LL DO

Setting Strategy

Establish and execute a long-term QA and regulatory compliance vision that incorporates processes and technology:

  • Develop and implementing the necessary strategies;
  • Build a QA and regulatory compliance team.


Driving projects

  • Work on obtaining Health Canada Standard Processing License for cannabis.
  • Help develop and implement the plan to establish a GMP-compliant contract research organisation (CRO) focused on psychedelic substance research:
    • Support the psychedelics research work accordingly from a license and regulatory perspective;
    • Drive Numinus's effort to obtain GMP certification and a Drug Establishment License as required;
    • Amend Dealer's License as required.
  • Expand Numinus’s clinic network across North America and develop a regulatory compliance plan to support clinic acquisition strategy.
  • Provide oversight for clinical research studies (section 56 exemptions).
  • Partner with research institutions for the administration of psychedelic-assisted therapy studies.


Regular Management

  • Update and maintain Standard Operating Procedures (SOPs) of the Health Canada cannabis testing license.
  • Maintain the OCS Dealer's license.
  • Fulfill reporting requirements to Health Canada as per legislation.
  • Sign off on external communications from a regulatory lens.
  • Align operational SOPs with corporate policies.
  • Alternate QAP for dealer's license.
  • Alternate head of lab for testing license.
  • Proposed QAP for processing license.

Job requirements

  • 10+ years hands-on and working QA experience in a GMP-focused quality-related position in cannabis, food, or pharmaceutical industry environment or equivalent.
  • 5+ years of management experience in quality systems and leading direct reports.
  • Several years’ experience in Regulatory Affairs or equivalent background.
  • Experience working directly with Health Canada on regulatory filings/strategy is required. Similar experience with the FDA is an asset.
  • A Bachelor degree or higher in life science (Biology, Chemistry, Microbiology, etc.)
  • Knowledge of or ability to learn the following legislation: Food & Drugs Act, Food & Drugs Regulations, Cannabis Act, Cannabis Regulations, Controlled Drugs and Substances Act, Narcotic Control Regulations and related legislation. Health Professions Act and equivalent across Canada. And equivalent legislation in the US.
  • Demonstrated ability to lead and manage within a complex, multi-site and matrix organization.
  • Exceptional research writing, and communication skills.
  • Health Canada security clearance an asset.
  • Must be legally permitted to work in Canada; preference to those already located in British Columbia.


MORE ABOUT NUMINUS BIOSCIENCE (Nanaimo)

Numinus Bioscience is an arm of Numinus, committed to helping its customers create safe and reliable products through analytical services and full-spectrum testing that take a consultative approach. Based in Nanaimo, BC, we use a combination of state-of-the-art equipment, acclaimed scientists, lab technicians, and proprietary methods that exceed Health Canada standards to ensure our results are accurate and validated. Our 7,000-square-foot facility is one of the largest testing labs in Western Canada, staffed by scientists who are passionate about providing our clients with accurate information about their products. With competitive pricing and industry-leading service times of 3-5 days, we take pride in being one of Canada’s most efficient and cost-effective cannabis focused laboratories.


In 2019, Numinus Bioscience was one of the first laboratories in Canada to be granted a narcotics dealer’s license for the testing and distribution of several medical psychedelic substances to support efforts towards addressing the growing trend of mental health issues. Effective June 12, 2020, Numinus Bioscience has a license amendment from Health Canada which allows us to produce and extract psilocybin from mushrooms. This positions Numinus as the first publicly-traded company in Canada permitted to conduct research to standardize the extraction of psilocybin from mushrooms.


Numinus, through Salvation Botanicals, is also a late stage applicant for a Health Canada Standard Processor License against its 3-room, 7,500-square-foot facility where it intends to produce cannabis finished goods for direct distribution to provincial distributors and retailers across Canada.


To learn more about Numinus’s other arms, visit numinus.ca.