Global Quality Systems Associate - Nanaimo, BC
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?
Ready to apply your talents to make a positive difference in the lives of patients across the country?
Reporting to the Global Quality Systems Manager, the Global Quality Systems Associate will be responsible for the successful on-going implementation of the Global Quality Management System (QMS) software program (Trackwise) at all Tilray subsidiary sites. This role will be responsible for providing guidance and training to essential key internal partners/stakeholders for alignment of Quality System programs and procedures. The position will include supporting development, implementation and administration of core QMS components including document control, training, change control, auditing and complaints management at a global level of the organization.
Roles and responsibilities
- Provide Subject Matter Expert training in the Quality Management System (QMS) software to enable subsidiary personnel to successfully implement and utilize the system at their sites for management of QMS core components and KPI reporting
- Consult with and assist the sites during the QMS implementation stages with the harmonization and transition of core program component processes and documentation into Trackwise: Document Control, Training, Deviations/CAPAs, Complaints, etc.
- Create training materials as required to enable sites to function independently; train the trainer
- Consult, collaborate and coordinate the development of global QMS document type templates for use at all sites in alignment with the published Quality Policies of the QMS
- Develop and maintain the Global Change Control procedure, including communication pathways for escalation of change from sites to Global, cross-facility review and approval by affected stakeholders, and dissemination of approved Global changes to sites
- Integrate the existing Global QMS Document Library into the Trackwise system
- Support the Global Quality group in other aspects of the development and maintenance of the Global Quality system e.g. Stability Program, Third Party Compliance/Supplier Management, Internal Auditing
- An undergraduate degree in the sciences or related field
- Experience implementing and maintaining quality management systems and programs (ISO, GMP, HACCP) is required
- Minimum 2 years direct cGMP quality management system experience in product manufacturing pharmaceutical, or healthcare related field
- Knowledge of the Cannabis Act and Regulations, Food and Drugs Act and Regulations, Controlled Drugs and Substances Act and Regulations, ICH, EU GMP, CFR is an asset
- Advanced MS Office software competency and aptitude for computer systems and software programs utilization and trouble-shooting, experience with Trackwise an asset
- Ability to communicate effectively
- Ability to work on multiple projects at the same time
- Flexibility and ability to adapt to change in a fast-paced environment with deadlines
- Ability to work well both independently and in a team environment
- Fluency in English (written and spoken)