administrative assistant

Job description

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 include:

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 participates in audits and inspections
12. 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
13. Ability to travel up to 30% in Canada
14. Identify and implement defined goals and objectives aligned with Gilead/Kite strategic initiatives
15. 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 objective/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