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Product Quality Coordinator

Tilray
Nanaimo BC
FULL-TIME EMPLOYMENT
  • Demonstrating leadership and initiative, ensuring product quality data is collected, stored and accessible to all relevant teams
  • Practicing strong scientific rigour, attention to detail, meticulousness in all file data
  • Performing CMC technical writing and editing assignments related to the preparation of CMC components of regulatory submissions for INDs, NDAs, ANDAs and other technical documents including content templates, as well as any other documents determined to be within the scope of the role; and ensure that project time-lines are met
  • Utilizing sound judgment in applying regulatory requirements, accurately analyzing and verifying file content to ensure production of high-quality written documents
  • Using the experience in process development, identify technical inconsistencies and participate in a resolution by performing proper assessments in order to anticipate questions and critical issues
  • Clearly responding to questions from Global Regulatory related to regulatory submissions in a structured and organized approach
  • Regularly monitoring commitments/obligations in response to regulatory requirements or requests
  • Building relationships of trust and demonstrating professional ethics
  • Ensuring changes in manufacturing or specifications are relayed to the regulatory team
  • Utilizing strategic thinking as well as analytical and synthesis skills, to assist in implementing electronic product quality data capturing and organization
  • Revising and approving the information in the product monograph and finished-product documentation
  • Properly preparing data by working with cross-functional teams; liaising with regulatory team for annual notification of changes pertaining to the data
Qualifications
  • An undergraduate degree in science, biology, chemistry, biochemistry, toxicology, pharmacy, pharmacology, health care or a related discipline
  • Minimum three years of relevant experience in any regulated product quality setting  
  • Advanced MS Office software competency
  • Ability to communicate effectively, negotiate, and persuade
  • Ability to work on multiple projects at the same time
  • Flexibility and ability to adapt to change
  • Ability to work well both independently and in a team environment
  • Diplomacy and ease in establishing and maintaining interpersonal relationships
  • Fluency in English (written and spoken)
  • Experience with CMC modules I, II, III and international regulations and file transfers
  • Experience with eCTD and non-CMC regulatory affairs is an asset
  • Adhere to company Style Guide, templates, SOPs and revision control for document development

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Tilray

Tilray operates medical cannabis research and production facilities.