Manager, Quality Assurance – Western U.S. (West of the Mississippi) & Florida

Gilead Sciences

14d • $123,930 - $160,380

About The Position

Kite is seeking a highly motivated, self-driven individual to join the North America Regional Quality Operations team as a Manager, Quality Operations, supporting CAR-T cancer immunotherapy. The role works cross-functionally to help qualify and monitor apheresis collection and treatment centers (ATCs), supporting the expansion of Kite’s commercially marketed cell therapy products. Candidates must reside in the Western U.S. (west of the Mississippi) or Florida when applying.

Requirements

• Currently reside in the Western U.S. (west of the Mississippi) or Florida at the time of application.
• Bachelor's degree and six years of experience, or master's degree and four years of experience, or PhD/PharmD.
• Proficient in MS Word, Excel, and PowerPoint.
• Excellent interpersonal, verbal, and written communication skills.
• Able to work independently, multitask, and prioritize responsibilities.
• Self-motivated and detail-oriented, and willing to accept temporary responsibilities outside the initial job description.
• Comfortable working in a fast-paced, small-company environment with minimal direction and adjusting workload as priorities change.

Nice To Haves

• Bachelor’s degree in biological sciences, nursing, medical technology, or a related field.
• Eight years of progressive experience in a medical or pharmaceutical environment, including nursing, apheresis/transplant/infusion centers, or blood banks, or in pharmaceutical, vaccines, or biologics quality systems.
• Three to five years of quality assurance experience.
• Experience managing external suppliers, blood banks, and plasma centers.
• Medical center or pharmaceutical auditing experience.
• Experience in Clinical Research, Medical Liaison, Apheresis, Cell Therapy Lab, or Medical Centers.
• Experience with deviation management, developing corrective and preventive actions, and change control.
• ASQ Certified Quality Auditor certification.
• Strong working knowledge of and ability to apply GMP and FACT/AABB standards.
• Experience presenting to and responding to regulatory agency or certification audits.

Responsibilities

• Assess and approve changes to Kite Konnect, courier tracking, order intake, and order processing systems to ensure their validated state is maintained.
• Assist in managing apheresis and treatment center qualification using risk-based tools for qualification, training, monitoring, and disqualification.
• Collaborate with Commercial Operations on routine management of ATC relationships and with Supply Chain on courier qualification and monitoring.
• Perform audits and qualify and monitor compliance with qualification requirements.
• Maintain the monitoring schedule and approved ATC list.
• Assist with resolution of ATC and courier issues and discrepancies, including related investigations.
• Support and/or own quality records, including ATC records, deviations, CAPA, and change control.
• Assist in developing, implementing, and managing the ATC management system (GVault).
• Support inspection-readiness plans and interact with regulatory agencies during inspections on ATC-related matters as needed.

Benefits

• May be eligible for a discretionary annual bonus.
• May be eligible for discretionary stock-based long-term incentives; eligibility may vary by role.
• Paid time off.
• Company-sponsored medical, dental, vision, and life insurance plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager