Senior Manager, Quality Assurance - Site Qualification

Employer
Kite Pharma
Location
El Segundo, CA, United States
Posted
Aug 12, 2019
Ref
R0008672
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
We are seeking a highly motivated individual to join us as Senior Manager, Quality Assurance - Site Qualification to work with the Quality team in supporting our efforts in this exciting new area of cancer immunotherapy. You will work cross functionally to assist with the development and implementation of a qualification and monitoring program for medical apheresis and treatment centers that supports Kite's rapid expansion of our first commercially marketed cell therapy product.

Responsibilities include (but are not limited to):
Assist in management of the collection app system.
Assess and approve any changes to collection app, 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 that will use 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 selection 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.)
Assess and approve any changes to collection app, courier tracking, order intake and order processing systems to assure validated state of the systems is maintained
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, as needed.
Ability to travel up to 40%
Perform other duties as assigned

Qualifications:
Bachelor's degree in biological sciences, nursing, medical technologist or related field and 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.
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 and Cell Therapy Medical Centers preferred.
Previous experience in deviations, corrective preventive/actions and change control, preferred.

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
Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.

IND123

#LI-ZN1

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

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