Quality Assurance Compliance Manager - Nanaimo, British Columbia
Tilray is a federally licensed producer of medical cannabis. We are committed to setting the gold standard of care and excellence in our industry. We believe that commitment starts with a great work environment and benefits for our associates.
Looking to develop your career at the forefront of a rapidly expanding industry?
Reporting to the Senior Quality Manager and working closely with each of the Tilray Nanaimo Quality, procurement, facilities, project management, production, processing and manufacturing teams ensuring compliance with regulatory, corporate, internal and external audit requirements. This role will be responsible for writing, implementing, training and improving quality assurance management programs and procedures and will watch over the day-to-day facility operations to ensure adherence to all quality and regulatory standards. The Quality Assurance Compliance Manager will be responsible for the coordination and maintenance of the Tilray document control, change control, validation, deviation/CAPA systems, external and internal auditing programs ensuring Tilray facilities meet or exceed the Tilray Quality standards, Eudralex GMP Part I and II guidelines and the Cannabis Regulations.
Role and Responsibilities
- Ensures compliance of all GxP related aspects of the Tilray Canada Ltd QMS with Tilray Quality standards, Eudralex GMP Part I and II guidelines and the Cannabis Regulations
- Manages and be accountable for Quality Control compliance team duties and schedule
- Ensures internal audit schedule, and audit reports containing findings, evaluation of auditee responses (including timeline for proposed corrective actions, commensurate with the risk) and follow-up verification of agreed upon corrective/preventive actions are communicated and adhered to be internal and external stakeholders
- Leads Quality Assurance System improvements in a self-directed manner and prioritizes at their discretion, by utilizing prescribed guidelines or policies to analyze and resolve problems in a collaborative manner with multiple stakeholders. These improvements will be driven from data provided or interpreted by complaints, deviations, CAPAS, validations, internal and external audits
- Develops and facilitates training to all manufacturing departments regarding regulatory requirements for GMP compliance and to further build knowledge of the organization
- Impacts and influences internal and external stakeholders to ensure Trackwise audit, documentation, change control, training, deviation and CAPA modules are maintained and complied with during the implementation phase and based on observations from internal auditing and deviation/CAPA reports
- Provides direction from findings of internal audits, changes from Quality Assurance System updates to internal stakeholders through change control, and non-compliance to deviation and CAPA systems verbally and through classroom training
- Provide administrative support towards quality agreements with all third-party vendors including licensed producers, raw material suppliers, testing labs, and warehouses by updating Tilray Nanaimo Quality Systems to ensure requirements from the quality agreements are met
- At their discretion, conducts self-inspection audits of the Tilray facilities to ensure compliance with Tilray procedures and the Cannabis act and Cannabis Regulations, and demonstrates good judgment within defined guidelines and practices to determine appropriate action
- Supports the Quality Assurance Compliance team creation and issuance of self-inspection audit reports containing findings, evaluation of auditee responses (including timeline for proposed corrective actions, commensurate with the risk) and follow-up verification of agreed upon corrective/preventive actions
- Responsible for ensuring mock recalls on a bi-annual basis on raw materials and finished product to ensure compliance with Tilray Nanaimo procedures and the Cannabis act and Cannabis Regulations, by tracing raw materials and or finished product throughout the system and evaluating data and leading the improvements required for compliance in Quality Systems
- Provides expertise during regulatory inspections of the Tilray facilities, by providing necessary documents to auditors and providing detailed explanation to the auditors
- Champions continuous improvement initiatives and department-level operational activities/projects
- Establish Quality performance goals, making certain key objectives of the GMP program are met
- Encourage modifications that simplify compliance with GMP requirements
- Develop, implement, and maintain GxP quality systems within department to ensure product quality and/or regulatory compliance
- Monitor all GxP related data for compliance to ACMPR and Tilray Quality systems and lead corrective action required
- Integrate improvements into site QMS from IQ/OQ/PQ program for equipment and processes
Qualifications and education requirements
- Bachelor’s degree in a technical discipline (Food, Physical, or Biological Sciences preferred)
- 5+ years of experience as a Quality Manager or Supervisor in a GPP, GMP and/or HACCP regulated environment required
- Strong leadership and communication skills
- Direct experience participating in, managing, or conducting quality audits and inspections
- Strong knowledge of the requirements of the Cannabis Regulations and CGMPs would be an asset
- Ability to assess risk using Quality Risk Management tools and advise senior management on risk mitigation strategies
- Excellent communication skills - written and verbal
- Proven ability to effectively use Microsoft Office Applications
- Achievement oriented individual with proven experience delivering results
- Able to develop, review, and maintain metrics and audits
- Strong work ethic and positive team attitude
Tilray welcomes applications from all qualified individuals and is committed to employment equity and diversity in the workplace.
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