THIRD PARTY COMPLIANCE MANAGER, GLOBAL QUALITY, 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 Director, Global Quality Systems, the Third Party Compliance Manager is the owner of the Third Party Management Program. Responsible for the establishment, implementation and maintenance of the policies and procedure for third party management. This position will collaborate with essential key internal partners/stakeholders to ascertain Quality/business requirements to establish effective and timely Quality Agreements with various types of GMP suppliers/service providers, customers and strategic alliance/marketing partners. The overall goal of the position is to establish successful business relationships and GMP responsibilities in alignment with Global QMS objectives and applicable regulations.
Role and Responsibilities
- Develop the global Third Party Management Program
- Develop and implement Third Party Quality Risk Assessment tools
- Own Third Party auditing and performance monitoring program for global suppliers and service providers
- Develop and standardize QAG templates for use with contract testing laboratories, excipient and raw material suppliers, domestic and international product distribution partners, outsourced GMP activity providers where required
- Perform risk assessment of proposed terms/quality provisions in QAGs (or other Commercial Agreements) and develop recommendations to minimize their potential risk to the business
- Ensure the completion of applicable reviews of QAGs by key stakeholders (Site Quality Managers, Production/Operations, Supply Chain Management, Legal/Compliance and/or other applicable Subject Matter Experts), obtaining leadership approvals, as required, to ensure corporate quality goals are operationally correct and accurately reflected in the QAG.
- Ensure QAGs are in alignment and not conflicting with the primary, business agreement and clearly delineate good manufacturing practice (GMP) responsibilities between a sponsor and a contractor
- Respond to requests and enquiries related to QAGs (content/statuses, etc.) from internal stakeholders
- Assist in the development and implementation of policies, standards, SOPs, work instruction/job aids for the management of Third Parties and compliance monitoring thereof
- Manage external communications related to manufacturing, specification, personnel or other business changes that affect QAGs, and execution of required QAG changes
- Audit suppliers and service providers for conformance/compliance with the terms of QAGs and applicable regulations
- Perform administration and maintenance duties related to the Global QAG database/tracker to reflect real time data/status; and preparation of QAG/Program metrics/status reports and presentations to Senior Leadership
- 8+ years of relevant experience in the pharmaceutical industry and a BS or BA.
- 6+ years of relevant experience and a MS
- Minimum 3 years direct quality agreement experience in drug development/regulatory, affairs, product manufacturing or healthcare related field either domestic or international.
- Strategic and technical knowledge for managing global quality agreement processes for various types of suppliers and service providers
- Supplier management or audit management experience
- Knowledge and experience working within a pharmaceutical manufacturing, packaging, and/or warehousing cGMP Quality Management System.
- Knowledge of the Canadian Access to Cannabis for Medical Purposes Regulations, Cannabis Act and Regulations, Food and Drugs Act and Regulations, Controlled Drugs and Substances Act and Regulations