Quality Assurance Manager (Remote - Quebec / Ontario)

Gilead Sciences; Edmonton; Remote; CAD 80,000 - 120,000; Full time

Job summary

An innovative company is seeking a Quality Assurance Manager to lead compliance activities in the fast-paced field of cancer immunotherapy. In this remote role, you will oversee product quality, manage regulatory submissions, and ensure adherence to Health Canada regulations. With a focus on collaboration and continuous improvement, you will play a crucial role in maintaining the highest quality standards for life-changing therapies. If you are passionate about making a difference in healthcare and possess strong organizational and communication skills, this is an exciting opportunity to contribute to groundbreaking advancements in cancer treatment.

Qualifications

• 6+ years of pharmaceutical quality experience, preferably in biological drug products.
• Strong knowledge of QA systems and regulatory requirements including Health Canada GMP.

Responsibilities

• Oversee product complaint management and quality management systems.
• Perform audits and qualify treatment centers to ensure compliance.
• Collaborate with various teams to execute tasks and projects.

Skills

Pharmaceutical Quality Experience

Knowledge of QA Systems

Bilingual Proficiency (French and English)

Strong Organizational Skills

Communication Skills

Interpersonal Skills

Ability to Work Independently

Ability to Work in Teams

Education

Bachelor’s Degree in Life Sciences

Bachelor’s Degree in Engineering

Job description

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 fulfill 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 revolutionizing individually tailored treatments. This environment is fast-moving and constantly changing, with daily discoveries including our own capabilities and individual potential.

We are currently seeking a highly motivated individual to join us in our journey developing innovative cancer immunotherapies and translating them into patient treatments.

We are looking for a Quality Assurance Manager to join Gilead Sciences Canada’s Quality Assurance team. This role supports Canada’s quality and regulatory compliance activities.

This is a remote role, preferably based in Quebec or Ontario.

Key Responsibilities include:

1. Release Kite products imported for distribution in Canada
2. Oversee product complaint management, including review and approval of investigations
3. Review and approve Annual Product Reports
4. Compile, review, and approve Yearly Biologic Product Reports; coordinate submissions to Health Canada
5. Support activities related to maintaining the Drug Establishment Licence for Kite imported products
6. Perform lifecycle activities such as batch record reviews and stability assessments
7. Manage change control and deviation quality records
8. Oversee quality management systems to ensure compliance with Health Canada regulations
9. Perform audits and qualify treatment centers (ATCs)
10. Assist in managing ATCs, including training and change management
11. Support inspection readiness and participate in audits
12. Collaborate with various teams within Gilead/Kite to execute tasks and participate in projects
13. Ability to travel up to 30% in Canada
14. Align goals with Gilead/Kite strategic initiatives
15. 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, preferably in biological drug products
• Bilingual proficiency in French and English
• Knowledge of QA systems, manufacturing, testing, and regulatory requirements including Health Canada GMP
• Strong organizational, communication, and interpersonal skills
• Ability to work independently and in teams