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Manager, Quality Assurance

Gilead Sciences, Inc.

This is a Full-time position in Vaughan, ON posted December 5, 2022.

Kite is continuing to hire for all open roles.

Our interview process may be conducted virtually and some roles will be asked to temporarily work from home.

Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Kite Pharma Employees and Contractors: Please log onto your Internal Career Site to apply for this job.

Job Description Being Here Matters At Gilead, Creating Possible drives everything we do.

It’s evident in our mission and core values.

This is how we built a culture of excellence that is fueled by a passion for improving the lives of people around the world and advancing the care of patients suffering from life threatening diseases.

We are driven to develop lifesaving products that make a difference for patients around the world.

Every day, we aim to transform the promise of science and technology into breakthrough, innovative therapies that have the power to cure, prevent or treat disease.

As a research-based bio pharmaceutical company, we are revolutionizing healthcare by bringing medicines to patients in the areas of unmet need including HIV/AIDS, liver diseases, hematology, oncology, and inflammatory diseases.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives.

The Role: 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.

Release Kite products imported for distribution in Canada Oversee all aspects and execution related to product complaint management for Canadian product complaints that includes intake of product complaints, review and approval of investigations Review and approve Annual Product Reports Compile, review and approve Yearly Biologic Product Reports and coordinate submissions of reports to Health Canada Support activities associated with the maintenance of Drug Establishment Licence for Kite imported products that includes foreign buildings involved in licensable activities Perform Importer quality product annual lifecycle activities such as batch record and ongoing stability reviews Initiate, review, approve, as applicable change control and deviation quality records 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 Works 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 Interact with Canadian hospitals for matters related to Kite products in Canada Participates in audits and inspections Identify and implement defined goals and objectives aligned with Gilead/Kite strategic initiatives Perform other duties as assigned Knowledge, Experience and Skills Bachelor’s degree in Life Sciences, Engineering or equivalent Minimum 6 years of pharmaceutical quality experience in a manufacturing or import/distribution settings; biological drug product experience is preferred Comprehensive knowledge of QA systems, manufacturing and testing processes and related regulatory requirements including Health Canada Good Manufacturing Practices Ability to adapt to change to meet objectives / deadlines and business priorities Ability to work with a high level of integrity, accuracy, and attention to detail to consistently meet high standards required in compliance Strong organizational skills in order to maintain a high level of productivity, innovation, and priority-setting in order to complete assignments Excellent judgement and personal initiative Ability to work alone and in cross functional teams Demonstrates excellent verbal, written, and interpersonal communication skills Gilead Core Values Integrity (doing what’s right) Teamwork (working together) Excellence (being your best) Accountability (taking personal responsibility) Inclusion (encouraging diversity) Gilead Leadership Commitments I AM BOLD in aspiration and AGILE in execution.

​I CARE and make time for people.

​I LISTEN, speak openly and explain the “why.” ​I TRUST others and myself to make sound decisions.

​I OWN the impact of my words and actions We are committed to creating a healthier world for everyone – no matter the challenges ahead of us.

Through bold and transformative science, we’re driving innovation that has the potential to become the next generation of life-changing medicines.

Our ambition is evident in our mission.

Because the impossible is not impossible.

It’s what’s next.

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care.

The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system’s ability to recognize and kill tumors.

Kite is based in Santa Monica, CA.

For more information on Kite, please visit www.kitepharma.com .

Sign up to follow KitePharma on Twitter at www.twitter.com/kitepharma .

For Current Kite Pharma Employees and Contractors: Please log onto your Internal Career Site to apply for this job.