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Quality Assurance, Team Lead

3 months ago

Frederick, Maryland, United States Gilead Sciences, Inc. Full time

For Current Kite Pharma Employees and Contractors:

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

We're here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We've made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

Job Description

Kite, a Gilead Company, is a biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the impactfulness of a patient's own immune system to selectively target cancer cells. Our core technology involves the genetic engineering of T cells, or white blood cells, to express either chimeric antigen receptors (CARs) or T cell receptors (TCRs) for the treatment of advanced hematological malignancies. We are on a rapid growth trajectory and have a highly energized and accomplished team motivating to new frontiers of care for cancer patients.

We are seeking a highly motivated individual to join us as Quality Assurance, Team Lead at our commercial manufacturing site in Frederick, MD. In this position, you will provide Quality Assurance oversight of Commercial Manufacturing, Materials Management, and Quality Control areas. Must be proficient in Quality Systems, particularly associated with Operations, Lot Disposition, Change Control and Exception Management / CAPA.

Shift is Wed-Sat * __*

Responsibilities include (but are not limited to):

  • Work with the Commercial Manufacturing, Quality Control, Materials Management and Facilities/Engineering departments as a Quality Assurance representative.
  • Coordinate and facilitate Quality Assurance related production and production related activities, including:
  • Assessment and closure of discrepancies, deviations and change controls requests.
  • On-the-floor support Quality support to manufacturing and QC staff.
  • Assessment and closure of laboratory investigations.
  • Timely assessment and closure of batch and material hold events.
  • Review of batch manufacturing and testing documentation for timely delivery of final product.
  • Ensure that tests are performed, and products are manufactured in compliance with Kite specifications, regulatory and GMP guidelines.
  • Compile and verify all batch related documents into a final product lot disposition package.
  • Perform/review and approve quality investigations of manufacturing deviations, GMP and quality system issues, non-conforming materials, and CAPA.
  • Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues.
  • Manage day-to-day activities for the initiation, tracking, and closure of non-conformances and CAPA activities.
  • Provide periodic updates to stakeholders for deviations, GMP and system issues, non-conforming materials and products and CAPA.
  • Perform other duties as required.

Basic Qualifications:

  • Master's Degree and 3+ years' experience in Quality Assurance, Lab setting or regulated environment OR
  • Bachelor's Degree and 5+ years' experience in Quality Assurance, Lab setting or regulated environment OR
  • High School Degree and 9+ years' experience in Quality Assurance, Lab setting or regulated environment OR

Preferred Qualifications:

  • Proficient in Quality Systems, particularly associated with Operations, Lot Disposition and Exception Management/CAPA.
  • Thorough knowledge of GMP, SOPs and quality systems.
  • Ability to effectively negotiate and develop collaboration amongst individuals.
  • Excellent interpersonal, verbal and written communication skills.
  • Experience with laboratory investigations, deviations, and CAPA.
  • Experience with change control practices and strategies.
  • General knowledge of aseptic manufacturing processes.
  • Proficient in MS Word, Excel, Power Point and other applications.
  • Ability to communicate and work independently with scientific/technical personnel.
  • Comfortable in a exciting small company environment with minimal direction and able to adjust workload based on changing priorities.

Does this sound like you? If so, apply today

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The salary range for this position is: $104, $135, 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:

  • 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 . Sign up to follow @KitePharma on Twitter at .

For jobs in the United States:

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 for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' ) poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT )

YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION )

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

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 $) 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.