Site Quality Project Coordinator- Nanaimo, BC
1 Year Temporary Role
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 Sr Quality Manager, the Site Quality Projects Coordinator is responsible for integrating GMP projects, new products, and global quality management systems projects into the Site Quality Management System. Ensure projects are planned and implemented in full compliance with all ACMPR, EU GACP, GMP, GDP, GVP and 21CFR Part 11 requirements as applicable. Act as the advisor to Quality Assurance/Quality Control and operations teams on the interpretation of quality requirements at different stages of project realization.
Roles and responsibilities
- Demonstrate a high level of autonomy and initiative, anticipating needs and addressing those needs in a timely and sensitive manner.
- Drive implementation of IT Quality systems e.g. LIMS and Trackwise
- Advise Operations, with Management support on complex quality assurance questions
- Act as Quality point of contact for new projects, utilizing strong relationship building skills to involve appropriate stakeholders at the appropriate times
- Demonstrate sound judgement with how departments, processes and challenges matrix into each other and how changes in one area will impact other stakeholders
- Liaise with Global Quality department for planning and implementation of new contracts/business models
- Ensure project plans, project scope, resources and roles & responsibilities are defined in accordance with the applicable regulatory requirements.
- Ensure the needs of the different quality requirements are accounted for during concept development and project execution.
- Collaborate with site operations and facility teams to managing risks and advocates for solutions in compliance with regulatory expectations.
- Collaborate with business owners to ensure overall performance of the project and project completion documentation is accurate and available
- Report to senior management on project performance and escalate potential compliance gaps or project delays.
- Participate in regulatory inspections and be responsible to present the quality elements of Quality Projects
- Undergraduate degree in Chemistry, Biochemistry or Biotechnology or equivalent, preferred, Masters degree an asset or extensive experience and related training
- Fluent in English required (oral & written).
- Minimum 2 years of LIMS software experience preferred.
- Good knowledge of GMP, working knowledge in technical development, production or QA.
- Excellent organizational and decision-making skills.
- Proven ability to analyze and evaluate GMP compliance.
- Minimum 2 years of working experience in a regulated industry.
- Must be a good team player with good communication skills