[Hiring] Manager, Quality Assurance @Gilead Sciences

Role Description

Kite is seeking a highly motivated, self-driven individual to join the North America Regional Quality Operations team as Manager, Quality Operations in the exciting new area of CAR-T cancer immunotherapy. You will work cross functionally to assist with the qualification and monitoring program for apheresis collection and treatment centers that supports Kite’s rapid expansion of our commercially marketed cell therapy products.

• Assess and approve any changes to Kite Konnect, courier tracking, order intake and order processing systems to assure validated state of the systems is maintained.
• Assist in the management of an apheresis and treatment center (ATC) qualification process using risk-based tools for qualification, training, monitoring and disqualification.
• Collaborate with our Commercial operations in the routine management of the ATC relationships and Supply Chain for courier qualification and monitoring processes.
• Perform a variety of audits, qualify and monitor compliance to qualification requirements.
• Maintain the monitoring schedule and approved ATC list.
• Assist with resolution of ATC and courier issues and discrepancies, and the investigations to resolve the issues.
• Support and/or own quality records (ATC, Deviations, CAPA, Change control, etc.)
• Assist in development, implementation and management of ATC management system (GVault).
• Support inspection readiness plans and interact with regulatory agencies during inspections on ATC-related matters, as needed.
• Ability to travel up to 40%.

Qualifications

• Bachelor's Degree and Six Years' Experience OR Masters' Degree and Four Years' Experience OR PhD / PharmD.

Requirements

• Bachelor’s degree in biological sciences, nursing, medical technologist or related field.
• 8 years progressive experience in a medical or pharmaceutical environment, including nursing, apheresis/transplant/infusion centers, or blood banks, preferred; OR pharmaceutical, vaccines or biologics quality systems’ roles.
• Minimum 3-5 years quality assurance experience preferred.
• Experience managing external suppliers, blood banks, and plasma centers.
• Medical center or pharmaceutical auditing experience preferred.
• Experience in areas such as Clinical Research, Medical Liaison, Apheresis, Cell Therapy Lab, and Medical Centers preferred.
• Previous experience in deviation management, development of corrective preventive/actions and change control, preferred.
• ASQ Certified Quality Auditor preferred.
• Strong working knowledge of and the ability to apply GMP and FACT/AABB standards.
• Previous experience presenting and responding to regulatory agency or certification audits, preferred.
• Proficient in MS Word, Excel, and Power Point.
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
• Must be able to work independently, can multi-task and prioritize job responsibilities.
• Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.

Benefits

• The salary range for this position is: $123,930.00 - $160,380.00.
• This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
• Benefits include company-sponsored medical, dental, vision, and life insurance plans.