Global Stability Program Lead
CANTANHEDE - PORTUGAL

Tilray is a global leader in medical cannabis research and production dedicated to providing safe, consistent and reliable therapy to patients. We are the only GMP certified medical cannabis producer currently supplying products to thousands of patients, physicians, pharmacies, hospitals, governments and researchers in Australia, Canada, the European Union and the Americas. Our team of PhD scientists, botanists and master horticulturists are leaders in cannabis research and related agricultural sciences. We strive to improve scientific understanding of the potential applications of medical cannabis and have invested in developing continuing medical education programs for health care practitioners around the globe.

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 around the globe?

Please apply in English

Reporting to the VP, Quality, the Global Stability Program Lead (GSPL) 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 product registration and approval documents. The GSPL works closely with various levels of the organization and cross functionally to communicate and collaborate on projects.
Role and Responsibilities

• Designs and manages the stability program for all medical products globally.


• Champions improvements of the Stability Program, responsible for the assessment of the impact of changes on the overall Stability Program


• Lead out-of-specification (OOS), out of trends (OOT) analytical deviations


• Provide analytical/technical support to Operations


• 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


• Operate CAPA/deviation, training and compliance systems


• Develop and author SOPs


• Implement and improve Quality Systems to realise the highest quality standards attainable for all activities conducted by the company.


• Report on Quality Control Metrics


• Lead trending programs for all products on release and stability


• Build authentic relationships and participate in business meetings, as required, with suppliers and contract manufacturers and maintain all product-related, Quality Technical Agreements (QTA's).


• Ensure of compendial method updates implemented as appropriate for products


• Identify and implement Continuous Improvement programs as appropriate


• Work closely with other members of R&D/Quality/Operations teams and GMs to ensure delivery of key project objectives


• Assist with troubleshooting quality control issues when required.


• Maintain appropriate Quality Technical Agreements with all GxP vendors


• Supporting regulatory submissions as required

Qualifications and education requirements

• B.Sc./M.Sc. degree in Biological/Life Sciences/Bioengineering (Pharmacology, Molecular Biology, Biology, Chemistry) or extensive experience and related training.


• Demonstrated experience in using statistical analysis tools e.g. Minitab or SPC.


• Minimum 5 years in a mid management role with direct experience in drug development/quality control/stability centers related field; preferably in an international capacity.


• In depth understanding of analytical method development, quality control systems and stability procedures


• Strong understanding of regulatory requirements for movement of controlled/uncontrolled products between different global jurisdictions


• Knowledge and background in CMC (chemistry, manufacture and controls) is an asset


• Experience implementing and maintaining quality management systems in a GMP/GLP environment.


• 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 and global regulatory requirements


• Expert knowledge in ICH requirements governing product development and Stability Testing Requirements of new drug substances and products