Senior Manager, Quality Assurance - US Site Qualification

Employer
Kite Pharma
Location
South Region, United States - South Region, United States
Posted
Aug 29, 2020
Ref
R0014975
Required Education
Bachelors Degree
Position Type
Full time
Kite is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job

Job Description

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, as needed.

• 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

Qualifications:

• 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.

• 3+ 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 and Cell Therapy 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 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

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

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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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability,genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contactcareers@gilead.comfor assistance.

For more information about equal employment opportunity protections, please view the'EEO is the Law'poster.

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For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.