Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!
Kite is seeking a highly motivated, self-driven individual to join the US Site Qualification team as Senior Manager, Quality Assurance in the exciting new area of CAR-T cancer immunotherapy. You will work cross functionally to assist with the qualification and monitoring program for medical apheresis and treatment centers that supports Kite’s rapid expansion of our commercially marketed cell therapy product.
Responsibilities include (but are not limited to):
- Assist in management of the collection application system.
- Assess and approve any changes to collection application system, 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 (Deviations, CAPA, Change control, etc.)
- Assist in development, implementation and management of ATC management system (Oracle Agile)
- Support inspection readiness plans and interact with regulatory agencies during inspections on ATC-related matters.
- Ability to travel up to 40%
- Remote position based in the Midwest, South, or Mountain areas of the country (must live in the Central or Mountain time zone).
- Perform other duties as assigned
- MA/MS degree in biological sciences, nursing or medical technologist and 6 years of experience in a medical or pharmaceutical environment, including nursing, apheresis/transplant/infusion centers, blood banks, vaccines or biologics
- BA/BS degree in biological sciences, nursing or medical technologist and 8 years of experience in a medical or pharmaceutical environment, including nursing, apheresis/transplant/infusion centers, or blood banks, vaccines or biologics
- High School diploma and 12 years of experience in a medical or pharmaceutical environment, including nursing, apheresis/transplant/infusion centers, or blood banks, vaccines or biologics
- 3+ years quality assurance experience.
- Experience managing external suppliers, blood banks, and plasma centers.
- Medical center or pharmaceutical auditing experience.
- Experience in areas such as Clinical Research, Medical Liaison, Apheresis and Cell Therapy Medical Centers.
- Previous experience in deviation management, development of corrective preventive/actions and change control.
- ASQ Certified Quality Auditor
- Strong working knowledge of and the ability to apply GMP and FACT standards
- Previous experience presenting and responding to regulatory agency or certification audits.
- 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
- Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
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