Sr Manager, Quality Assurance

At Gilead Sciences Canada Inc. we take pride in being recognized as one of Greater Toronto’s Top Employer 2024. Click here to find out why Gilead Sciences Canada is a top employer! Chez Gilead Sciences Canada Inc., nous sommes fiers d’être reconnus comme l’un des meilleurs employeurs du Grand Toronto pour 2024. Cliquez ici pour en savoir plus sur les raisons de notre succès. At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.   Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.   We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Senior Manager, Quality Assurance Job Description We are seeking a Senior Manager, Quality Assurance to provide Quality oversight for the importation, release, distribution, and lifecycle management of commercial cell therapy products in Canada. This individual will work cross-functionally to represent the Quality Unit and support Kite's commercial operations in Canada. Responsibilities include product release, quality systems oversight, quality event management, regulatory compliance, Drug Establishment Licence (DEL) maintenance, support of authorized treatment centers, and collaboration with manufacturing sites and key business partners including Customer Service, Regulatory Affairs, Supply Chain, Medical Affairs, Commercial Operations, and Quality Compliance. This individual will provide quality guidance and support to ensure product quality, patient safety, and regulatory compliance while supporting business objectives.

Serve as delegate for the Canada Kite Quality Head, providing Quality guidance and operational support for Canadian activities. Perform release of commercial and clinical cell therapy products in accordance with approved procedures and applicable regulatory requirements. Provide Quality oversight for the importation, storage, distribution, and post-market support of commercial cell therapy products in Canada. Author, review, and approve Annual Product Reviews (APRs), Yearly Biological Product Reports (YBPRs), and other quality assessments, as applicable. Support maintenance of the Drug Establishment Licence (DEL), including renewals, amendments, inspections, and compliance activities. Own and approve quality records including deviations, CAPAs, change controls, complaints, investigations, and product quality impact assessments, as appropriate. Apply risk-based decision making when evaluating quality events, proposed changes, and compliance risks. Provide Quality oversight of manufacturing sites and Quality Agreements. Interact with authorized treatment centers, providing quality guidance and issue resolution support. Support internal audits, Health Canada inspections, and inspection readiness activities. Review and approve quality documents including procedures, reports, specifications, and other quality records, as appropriate. Monitor regulatory developments and assess potential impacts to Quality systems and business operations. Support continuous