Jobs for People with MS: National MS Society

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.

At Kite, we empower our leaders to step up, share ideas, listen, learn, and lead. We’re welcoming bright, diverse, and imaginative minds; we’re nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.

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, passionate 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):

• Collaborate with Commercial Operations and represent Quality for the qualification of authorized treatment centers (ATCs).

• Perform a variety of audits to qualify and monitor compliance to ATC qualification requirements.

• Represent Quality in the routine management of the ATC relationships and monitoring processes.

• Assist in the management of the ATC qualification process using risk-based instruments for qualification, training, monitoring and disqualification.

• Supports maintenance of the apheresis collection system and ATC quality management system

• Assess changes to ATC qualification systems, apheresis collection system, courier tracking, order intake and order processing systems to assure validated state of the systems is maintained.

• 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.)

• Support inspection readiness plans and interact with regulatory agencies during inspections on ATC-related matters, as needed.

• Remote position based in the Northeast (CT, NH, NJ, NY, MA, PA, VT, RI) area of the US

• Ability to travel up to 40%

• Perform other duties as assigned

Basic Qualifications:

• Doctorate OR

• Master’s and 6+ years of experience in a medical or pharmaceutical environment OR

• Bachelor’s and 8+ years of experience in a medical or pharmaceutical environment OR

• Associate and 10+ years of experience in a medical or pharmaceutical environment OR

• High School Diploma/GED and 12+ years of experience in a medical or pharmaceutical environment

Preferred Qualifications:

• Bachelor’s degree in biological sciences, nursing, medical technologist or related field

• Areas 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

• 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

• Excellent 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 n exciting small company environment with minimal direction and able to adjust workload based upon changing priorities

• Must be able to work independently, have the ability to multi-task and prioritize job responsibilities

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

Does this sound like you? If so, apply today

#LI-ML1

#IND123

The salary range for this position is: $139,995.00 - $181,170.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. 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*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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 contact ApplicantAccommodations@gilead.com for assistance.

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Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.

Change The World With Us

Everyone at Kite is grounded by one common goal – curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work.

We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don’t take success for granted.

While we’ve come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.