Position:  Quality Control & Stability Program Lead
Location:  Nanaimo, British Columbia
Job Id:  693
# of Openings:  1

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?
 
QUALITY CONTROL & STABILITY PROGRAM LEAD, GLOBAL QUALITY, NANAIMO, BC
 
Reporting to the Director of Global Quality, the Global QC and Stability Program Lead designs and owns the global stability program for all new and existing products. Responsible for maintaining Stability Program in compliance with global regulatory requirements. Provides technical expertise on the stability sections in CMC documentation. Supports drafting, compiling and controlling product development documentation to support international Product Registration and Market Launch initiatives. Owns the global LIMS and other global lab management and analytical platforms. Approves changes to global stability program and global Lab Management Systems. The ideal candidate is highly organized, has good regulatory strategic thinking, can adapt to changing priorities and demonstrates good communication, project management and problem-solving skills.
 

Role and Responsibilities

  • Designs and owns the global stability program for all new and existing products.
  • Champions improvements of the Stability Program, responsible for the assessment of the impact of changes on the overall stability program
  • Supports product development teams in the development of product specification and analytical methods’ improvements.
  • Participates in the preparation of regulatory submissions and preparation of CTD/DMF/QOS/SmPC where required
  • Ensure that scientific data supporting submissions are in compliance with the domestic and international regulations and all relevant guidelines and policies.
  • Respond to health authority requests in a timely manner

Qualifications 

  • M.Sc. degree in Biological/Life Sciences/Bio engineering (Pharmacology, Molecular Biology, Biology, Chemistry) or extensive experience and related training.
  • Minimum 5 years direct experience in drug development/quality control/stability centers related field; preferably in an international capacity.
  • In depth understanding of quality control stability procedures and relevant regulatory standards
  • Strong understanding of regulatory requirements for movement of controlled/uncontrolled products between different global jurisdictions
  • Strong ability to utilize statistical analysis tools and techniques for the evaluation of product shelf life and storage conditions
  • Strong technical knowledge of product development, global regulatory requirements
  • Demonstrated knowledge of Stability Testing Requirements of new drug substances and products ICH Q1A
  • Knowledge and background in CMC (chemistry, manufacture and controls) is an asset
  • Experience implementing and maintaining quality management systems and programs (ISO9001, GMP, HACCP, ACMPR, and EU GACP, GMP, GDP and GVP requirements) is an asset

Apply for this Position
Go back to the job list