Quality Assurance Manager (Remote - Quebec / Ontario)

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.

Job Description

Kite, a Gilead Company

At Kite, we are at the forefront of immunotherapy and engineered T cell therapy. We are helping change the paradigm of cancer treatment and we are revolutionizing individually tailored treatments. That means a fast moving and constantly changing environment, where we make discoveries every day – discoveries that include our own capabilities and our individual potential.

We’re currently seeking to recruit a highly motivated individual, to join us and be part of our exciting journey in the development of innovative cancer immunotherapies and their translation to the treatment of patients with cancer.

We are looking for a Quality Assurance Manager to join Gilead Sciences Canada affiliate Quality Assurance team. This position will be responsible to support Canada quality and regulatory compliance activities.

This is a remote role and can be based anywhere in Canada, preferably Quebec or Ontario.

Key Responsibilities:

1. Release Kite products imported for distribution in Canada.
2. Oversee all aspects and execution related to product complaint management for Canadian product complaints that includes review and approval of investigations.
3. Review and approve Annual Product Reports.
4. Compile, review and approve Yearly Biologic Product Reports and coordinate submissions of reports to Health Canada.
5. Support activities associated with the maintenance of Drug Establishment Licence for Kite imported products that includes foreign buildings involved in licensable activities.
6. Perform Importer quality product annual lifecycle activities such as batch records and ongoing stability reviews.
7. Initiate, review, approve, as applicable change control and deviation quality records.
8. Oversee quality management system for importer/distributor regulatory requirements that may include maintenance and implementation of standard operating procedures to comply with Health Canada regulatory requirements and Kite expectations.
9. Perform selection audits and qualify and monitor apheresis and treatment centers (ATCs) to qualification requirements.
10. Assist in the management of ATCs that includes training and changes management.
11. Support inspection readiness plans and participate in audits and inspections.
12. Work collaboratively with Gilead/Kite team in Quality, Regulatory Affairs, Supply Chain, Manufacturing and Commercial organizations to effectively execute tasks and to participate in projects representing Gilead Canada affiliate.
13. Identify and implement defined goals and objectives aligned with Gilead/Kite strategic initiatives.
14. Perform other duties as assigned.

Knowledge, Experience and Skills:

1. Bachelor’s degree in Life Sciences, Engineering or equivalent.
2. Minimum 6 years of pharmaceutical quality experience in a manufacturing or import/distribution settings; biological drug product experience is preferred.
3. Excellent communication and presentation skills with bilingual proficiency (French and English) is a requirement.
4. Comprehensive knowledge of QA systems, manufacturing and testing processes and related regulatory requirements including Health Canada Good Manufacturing Practices.
5. Ability to adapt to change to meet objectives/deadlines and business priorities.
6. Ability to work with a high level of integrity, accuracy, and attention to detail to consistently meet high standards required in compliance.
7. Strong organizational skills in order to maintain a high level of productivity, innovation, and priority-setting in order to complete assignments.
8. Excellent judgement and personal initiative.
9. Ability to work alone and in cross-functional teams.
10. Demonstrates excellent verbal, written, and interpersonal communication skills.

Ability to travel up to 30% in Canada.