Sr Manager, Quality Assurance

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At Gilead were creating a healthier world for all people. For more than 35 years weve 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads 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 were 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.

Job Description

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 Kites 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.

Responsibilities

• 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 improvement initiatives to strengthen Quality systems compliance processes and operational effectiveness.
• Provide project management support to ensure timely completion of Quality deliverables.
• Additional duties as assigned.

Basic Qualifications

• Bachelors Degree and 8 years of experience in Quality Assurance Quality Systems GMP Compliance or a related regulated environment

OR

• Masters Degree and 6 years of experience in Quality Assurance Quality Systems GMP Compliance or a related regulated environment

Preferred Qualifications

• Strong knowledge of Canadian GMP GDP Drug Establishment Licence (DEL) and Health Canada regulatory requirements.
• Experience with biologics sterile products cell therapy blood products tissues gene therapy products or other advanced therapies.
• Experience performing product release for commercial and clinical pharmaceutical or biologic products.
• Experience authoring and reviewing APRs and YBPRs.
• Experience supporting Health Canada inspections regulatory responses and inspection readiness programs.
• Experience managing deviations CAPAs change controls complaints investigations and quality risk assessments.
• Experience supporting Quality Agreements and oversight of manufacturing sites contract manufacturing organizations or third-party service providers.
• Demonstrates strong business acumen and ability to balance compliance requirements with operational and business needs.
• Demonstrates sound judgment and the ability to apply risk-based decision making in a regulated environment.
• Demonstrates excellent verbal communication technical writing and interpersonal skills.
• Demonstrates ability to influence cross-functional stakeholders through collaboration and expertise.
• Demonstrates strong customer and stakeholder management skills and ability to build productive working relationships across functions.
• Comfortable working with complexity and ambiguity while demonstrating strong critical thinking and problem-solving skills.
• Must demonstrate the ability to organize prioritize and manage time effectively.
• Comfortable in a fast-paced environment and able to adjust workload based on changing priorities.
• Demonstrates working knowledge and proficiency in Microsoft Office applications.
• French language capability is considered an asset.
• Experience working directly with hospitals or healthcare institutions is beneficial.

Please apply via the Internal Career Opportunities portal in Workday.

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