Quality Assurance Manager

About the Company:

Purileaf Brand Corporation is a privately held cannabis processing company located in Niagara Falls, Canada. An industry leader in manufacture of purified cannabinoids, Purileaf's core business operations include manufacturing of pure input ingredients for Canadian cannabis companies and commercialization of functional cannabinoid containing products. In business since 2016, Purileaf has experienced rapid growth by implementing targeted investments in production, technology, sales, and marketing.

Purileaf is currently completing construction and opening a new wing of it's manufacturing facility to triple the manufacturing floor space. With this expansion Purileaf is poised to become one of the largest cannabinoid manufacturing facilities in the country. This expansion coincides with our need to double the manufacturing output on wholesale and retail products based on current rate of client acquisition and new product listings with provincial cannabis distributors.

We are looking for experienced Quality Assurance Manager to oversee the quality monitoring and quality control in all aspects of Purileaf production processes in strict compliance with the Cannabis Act and other applicable regulations.

Responsibilities:

• Collaborate with and offer compliance guidance on quality control and regulatory affairs to ensure adherence to Health Canada regulations and EU GMP Guidelines.
• Approve product for transfer or sale.
• Manage and develop staff and perform documented performance reviews to communicate and discuss employee progress relative to established objectives.
• Monitor KPI's for quality at site and manage issue resolution as required.
• Act as Alternate QAP under direct leadership and supervision of the Director of Quality Assurance and Regulatory Affairs in ensuring that all QA/QC activities, e.g. testing, retention, room inspections, sanitation monitoring, room approvals, equipment and material files, operate effectively to support operations and transfer schedules.
• Develop, review, update and maintain SOPs and quality assurance procedures.
• Manage the laboratory environment to verify production quality and repeatability of strain production.
• Provide oversight of the implementation of the site quality system in-line with corporate quality objectives.
• Manage site quality inspection activities and where applicable, supplier quality assessments.
• Act as a site representative for Health Canada audits and coordinate response to findings.
• Ensure non-conformances, planned deviations, CAPA's, complaint and exception investigations are appropriately handled and approved.
• Approve validation studies and coordinate / support the validation program.
• Ensure that all products comply with the Canadian Act (incl. its Regulations ), and associated policies.
• Stay current with regulatory changes happening in Canada and within the provinces.
• Manage regulatory inspections, product transfers, security incidents, loss/thefts, adverse reactions, product destruction, and non-conformances.
• Review product labels and advertising.
• Produce and/or manage the yearly, quarterly, monthly and other inventory control related reports as required by the Cannabis Act.
• Manage site-specific document control functions.

Experience:

• Knowledge of quality standard methodologies in pharmaceutical or related industry,
• Experience in quality control, data management, GMP/GPP and validation principles and demonstrated success leading projects.
• 5+ years effectively managing and leading.
• Solid decision making.
• Project management experience.
• Strong root cause analysis and investigation expertise.
• Knowledge of and experience working with Health Canada's protocols.
• Strong management and leadership skills along with strategic thinking ability, and a proven track record of regulatory successes.
• Excellent communication in both oral and written formats.
• Superior organizational abilities.
• Strong scientific knowledge of drug product Chemistry, Manufacturing and Controls (CMC) documentation requirements.
• Experience implementing and maintaining quality management systems and programs (ISO9001, GMP, HACCP, ACMPR, and EU GACP, GMP, GDP requirements).
• Strong understanding of regulatory requirements for international transfer of controlled substances.

Requirements:

• B.Sc./M.Sc. degree in Biological/Life Sciences/Bioengineering (Pharmacology, Molecular Biology, Biology, Chemistry) or extensive experience and related training.
• Minimum 5 years management / supervision experience in QA/QC in the pharmaceutical, food, and/or cosmetics industry.
• Preference will be given to candidates with previous experience working with the Access to Cannabis for Medical Purposes Regulations and/or the Controlled Drugs and Substances Act.

Job Types: Full-time, Permanent

Pay: $85,000.00-$95,000.00 per year

Benefits:

• Casual dress
• Company events
• Dental care
• Disability insurance
• Extended health care
• Life insurance
• On-site parking
• Paid time off
• Vision care

Ability to commute/relocate:

• Niagara Falls, ON: reliably commute or plan to relocate before starting work (required)

Education:

• Bachelor's Degree (required)

Experience:

• Quality Assurance: 5 years (required)
• Pharmaceutical Industry: 5 years (required)
• Cannabis Industry: 5 years (preferred)

Work Location: In person