Gilead Sciences Inc

Sr Manager, Quality Assurance

Gilead Sciences Inc • $127K — $164K *
Mississauga, ON L4T 0A1In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's Degree with 8+ years in Quality Assurance or related field, or Master's Degree with 6+ years in Quality Assurance or related field.
  • Strong understanding of Canadian GMP, GDP, and Health Canada regulatory requirements.
  • Experience with biological products such as cell therapy and gene therapy.
  • Proven track record in performing product release for commercial and clinical products.
  • Demonstrated ability to manage quality systems including CAPAs and deviations.

Responsibilities

  • Serve as delegate for the Canada Kite Quality Head, providing Quality support for Canadian operations.
  • Perform product release for clinical and commercial cell therapy products per regulatory guidelines.
  • Oversee importation, storage, and distribution of commercial cell therapy products in Canada.
  • Author and review key quality documents like Annual Product Reviews and Biological Product Reports.
  • Maintain Drug Establishment Licence, ensuring compliance through renewals and inspections.
  • Monitor quality events and apply risk-based decision-making for evaluations.
  • Support audit readiness and inspection activities for Health Canada.

Benefits

  • Opportunities for career advancement in a leading biotechnology company.
  • Engagement in cutting-edge cell therapy projects with significant patient impact.
  • Collaboration with cross-functional teams to enhance professional growth.
  • Access to continuous learning and professional development programs.
  • Flexible work environment with potential for remote work options.
Full Job Description
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 Kite's 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
  • Bachelor's Degree and 8+ years of experience in Quality Assurance, Quality Systems, GMP Compliance, or a related regulated environment

OR
  • Master's 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.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.

The salary range for this position is CAD $127,415 - $164,890 annually. In addition, this role is eligible for a discretionary target annual bonus. Gilead determines base compensation by considering factors such as experience, qualifications, and geographic location. As a result, actual compensation may vary.

AI Clause

We use AI-enabled tools to support our recruitment process. All hiring decisions are made by our recruitment team.

About Gilead Sciences Inc

Gilead Sciences is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet need. With each new discovery and experimental drug candidate, they seek to improve the care of patients suffering from life-threatening diseases. Gilead's primary areas of focus include HIV/AIDS, liver disease, and serious cardiovascular and respiratory conditions.

Gilead Sciences Inc Careers

Join the vibrant team at Gilead Sciences Inc, a leader in the biopharmaceutical industry known for its innovative approach to healthcare. At Gilead, we are committed to advancing the care of patients around the globe through rigorous science and research.

Work You’ll Do

Embark on a career journey with Gilead Sciences Inc, where job opportunities abound in a variety of fields, from scientific research to marketing and sales. Our team is dedicated to fostering an environment of diversity and inclusion, where every employee can thrive.

Innovate and Lead

At Gilead, innovation is at the core of everything we do. Join us and contribute to our mission of saving lives through advanced treatments and cutting-edge medicine. Our leadership is committed to nurturing professional growth, making Gilead an ideal place for those who aim to lead and innovate in the healthcare industry.

Grow Your Career

Gilead Sciences Inc offers a wealth of career advancement opportunities. With personalized career development programs, employees are encouraged to pursue their professional interests and expand their skills. Whether through on-the-job learning, formal training, or leadership development, we provide the tools necessary for long-term career growth.

Be Part of Our Team

Our team at Gilead Sciences Inc is composed of passionate, curious, and solution-driven professionals. By joining us, you’ll collaborate with some of the brightest minds in the industry. Our culture promotes teamwork and an interdisciplinary approach to problem-solving, making our workplace dynamic and innovative.

Internship and Employment Opportunities

Start your career with Gilead through our internship programs, which offer hands-on experience in biopharmaceutical development and business operations. For seasoned professionals, our employment opportunities span across various disciplines, inviting you to bring your valuable skills to our team.

Benefits and Culture

Gilead Sciences Inc is not only a great place to work but also offers competitive benefits designed to support the health, well-being, and financial security of our employees and their families. From health insurance to retirement plans and wellness programs, we ensure our team members are taken care of.

Networking and Professional Development

We emphasize the importance of networking and professional development within the company. Regular workshops, seminars, and training sessions are held to enhance your skills and knowledge. Additionally, Gilead’s strong emphasis on internal networking allows for cross-departmental collaboration and innovation.

Join Our Hiring Events

Stay connected with Gilead by joining our hiring events and exploring open positions that match your skills and interests. We are always on the lookout for dedicated, creative, and driven team players. Prepare your resume, ace the interview, and take the first step towards a fulfilling career at Gilead Sciences Inc.

Explore Jobs at Gilead Sciences Inc

Discover the exciting career opportunities waiting for you at Gilead Sciences Inc. Visit our careers page to search for open positions, read about our company culture, and learn how you can make a difference in the global healthcare landscape.

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Keep informed with the latest company news, career tips, and industry insights—all from the people who work at Gilead Sciences Inc. Subscribe to our job alert emails and personalize your experience to receive updates that align with your career preferences. Join Gilead Sciences Inc today and be part of a team that values innovation, leadership, and a commitment to diversity and employee growth.
Learn more about Gilead Sciences Inc
Size
14,400 employees
Market Cap
$107.2 billion
Industry
Pharmaceuticals & Biotech
Net Income
$123 million
Founded
1987
5 Year Trend
-2.1%
Revenue
$24.6 billion
NASDAQ
GILD
* Ladders Estimates

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