Quality Assurance Lead

4 weeks ago

Mississauga, Ontario, Canada Gilead Sciences, Inc. Full time
Job Overview

At Gilead Sciences, Inc., we are dedicated to fostering a healthier future for individuals worldwide. With over 35 years of experience, we have confronted significant health challenges, including HIV, viral hepatitis, COVID-19, and cancer. Our relentless pursuit of innovative therapies aims to enhance lives and ensure their accessibility across the globe. Our mission is driven by collaboration, determination, and an unwavering commitment to making a positive impact.

Every member of our team plays a vital role in the discovery and development of transformative scientific advancements. Our workforce is our most valuable asset as we strive to achieve our ambitious goals, and we are seeking passionate and driven individuals ready to make a meaningful contribution.

We recognize that every employee deserves exceptional leadership. Our People Leaders are fundamental to the employee experience at Gilead. As a leader, you will be instrumental in shaping our culture and fostering an environment where every employee feels valued, developed, and empowered to reach their full potential. Together, we can create possibilities.

Key Responsibilities:

  1. Manage the release of Kite products imported for distribution.
  2. Oversee the execution of product complaint management for Canadian product complaints, including the review and approval of investigations.
  3. Review and approve Annual Product Reports.
  4. Compile, review, and approve Yearly Biologic Product Reports and coordinate submissions to regulatory authorities.
  5. Support the maintenance of Drug Establishment Licenses for imported products, including foreign facilities involved in licensable activities.
  6. Conduct annual lifecycle activities for quality products, including batch records and ongoing stability assessments.
  7. Initiate, review, and approve change control and deviation quality records as necessary.
  8. Manage the quality system for regulatory compliance, including the development and implementation of standard operating procedures.
  9. Conduct audits and qualify apheresis and treatment centers (ATCs) to meet qualification standards.
  10. Assist in the management of ATCs, including training and change management.
  11. Support inspection readiness initiatives and participate in audits and inspections.
  12. Collaborate with cross-functional teams in Quality, Regulatory Affairs, Supply Chain, Manufacturing, and Commercial sectors to effectively execute tasks and represent Gilead Canada.
  13. Willingness to travel up to 30% within Canada.
  14. Identify and implement goals aligned with Gilead's strategic initiatives.
  15. Perform additional duties as assigned.

Qualifications:

  1. Bachelor's degree in Life Sciences, Engineering, or a related field.
  2. A minimum of 6 years of experience in pharmaceutical quality within manufacturing or import/distribution environments; experience with biological drug products is preferred.
  3. Exceptional communication and presentation skills, with bilingual proficiency in French and English required.
  4. Thorough understanding of quality assurance systems, manufacturing and testing processes, and relevant regulatory requirements, including Good Manufacturing Practices.
  5. Ability to adapt to changing objectives and business priorities.
  6. Strong integrity, accuracy, and attention to detail to consistently meet compliance standards.
  7. Excellent organizational skills to maintain productivity and prioritize tasks effectively.
  8. Demonstrated sound judgment and initiative.
  9. Ability to work independently and collaboratively within cross-functional teams.
  10. Outstanding verbal, written, and interpersonal communication skills.

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