Quality Operations Specialist

**Quality Operations Specialist - Brampton, ON**

**_About Tilray Brands Inc._**

Tilray Brands is a leading global cannabis-lifestyle and consumer packaged goods company with operations in Canada, the United States, Europe, Australia, and Latin America that is changing people's lives for the better - one person at a time - by inspiring and empowering the worldwide community to live their very best life by providing them with products that meet the needs of their mind, body, and soul and invoke a sense of wellbeing. Tilray’s mission is to be the trusted partner for its patients and consumers by providing them with a cultivated experience and health and wellbeing through high-quality, differentiated brands and innovative products. A pioneer in cannabis research, cultivation, and distribution, Tilray’s unprecedented production platform supports over 20 brands in over 20 countries, including comprehensive cannabis offerings, hemp-based foods, and alcoholic beverages.
- Looking to develop your career at the forefront of a rapidly expanding industry?_

**_Job Summary:_**

The QO Specialist role entails a number of functions with an overall responsibility for monitoring and maintaining the Quality Systems to all relevant regulatory requirements (GMP/cGMP, EU GMP, Cannabis GPP) associated with the manufacturing, packaging, storage, and testing of products. They will pro-actively identify, facilitate and communicate Quality System related needs and gaps to ensure compliance by all governing regulatory requirements. Also to fulfill QAP/QPIC requirements as per the Cannabis Regulations.

**_Job Responsibility:_**
- The duties of the QO Specialist involve, but not limited to the following:

- Responsible for managing and overseeing Quality Management Systems (such as but not limited to the Change Control Program, Deviation/CAPA/Lab Investigations, Training etc).
- Provide Quality oversight to all validation activities at ARA’s site for equipment, computer systems, facility, cleaning, manufacturing and packaging to ensure Canadian, US and European regulatory requirement are met.
- Review and approve validation protocols and reports, as well as maintenance and repair reports for facilities and production/laboratory equipment.
- Ensures that all manufacturing, packaging, testing storage and distribution activities whether performed by ARA or by external parties on ARA’s behalf are in conformance with Health Canada, FDA or other applicable regulations and ARA or client requirements.
- Releases products for shipping /to market, as applicable.
- Reviews, participates in drafting, and approves quality documentation such as Change Controls, Deviations, CAPAs, TARs, OOSs, SOPs, risk assessments etc. Communicate status of these to departments to ensure timely closure and to perform trending when requested.
- Oversees and manages training initiatives, periodic review of training records and ensuring training records are compliant and up to date.
- Reviews, participates in drafting, approving, various documentation (such as but not limited to master batch records, executed batch records, logbooks, SOPs, lab books, test reports data packet, stability protocols and reports, method validation and/or method developments data, protocols and reports etc).
- Manages Vendor/Supplier Qualification program and Self Inspection Program.
- Coaches and leads staff including direct reports to ensure compliance and quality metrics are maintained throughout the Company.
- Participates/hosts in the client and regulatory audits and inspections.
- Work closely and efficiently with cross functional teams to ensure timely Quality input and oversight of projects.
- Assists in issuance, tracking, reconciling and archiving laboratory notebooks and other GMP documentation such as logbooks, forms, etc.
- Performs other tasks/duties as assigned.

**_Qualifications:_**
- University degree in Chemistry or related Science.
- Minimum 5 years of GMP and QA/QC related experience, preferably in the pharmaceutical or other regulated (e.g., food) industry in QA/compliance/QC, manufacturing or regulatory area.
- Demonstrated experience in a Supervisory and/or Leadership capacity
- Ability to effectively manage relationships with internal and external clients, vendors and contractors.
- In depth knowledge of cGMPs and related Health Canada Acts, FDA, and European regulations.
- In depth knowledge of cGDP and related documentation practices.
- Knowledge of MS Word, Excel and Outlook.
- Strong verbal and written communication skills Detail oriented with excellent decision making and problem-solving capability
- Flexibility of carrying multiple projects according to priorities in a rapidly changing environment
- Must contribute to and foster the development of a health and cooperative environment
- Must have the ability to work with mínimal supervision and to work well as part of a team Strong leadership or supervisory/managerial skills including delegation, tim