QA Specialist III

Were 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. Weve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But were 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

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.

We are seeking a highly motivated individual contributor to join us as a QA Specialist III within External Quality embedded within Kites External Quality Organization. The QA Specialist III will report to the Senior Manager External Quality. Scope of the External Quality group includes quality oversight of contracted service providers such as development and manufacturing organizations(CMO/CDMO) contract testing labs (CTLs) and quality support for Strategic Partnerships spanning clinical and commercial operations within the cell therapy space.

The QA Specialist III will have opportunities to work and share knowledge with partners across Kites Global Technical Operations (e.g. Quality Control Analytical Development Process Development Quality Manufacturing Supply Chain and Regulatory) as well as international partners. The ideal candidate will have a strong technical skills (knowledge of one or more of the following: cell therapy bioassays viral vector and testing operations) Quality and Compliance background (Biologics Drug regulation) and understanding of the drug development lifecycle.

This position will be based at Kites headquarters in Santa Monica CA.

Responsibilities of the QA Specialist III include:

• Quality support of one or more CMO/CDMO and execution of all day-to-day quality operational responsibilities.
• Authoring review and/or approval of GxP records and documents (both internal and external) including but not limited to: master and executed production batch records investigations corrective actions change controls protocols and reports annual product quality reviews IND/BLA/MAA CMC modules Quality Agreements.
• Compilation of critical material and product disposition packages. Project management of disposition deliverables (e.g. investigations batch records) ensuring timely critical material and/or product supply.
• Perform disposition (release) of product from CMOs.
• Ownership of critical issues or risks that emerge and provide mitigation recommendations to the team; monitoring performance related to performance of Kites CMOs.
• Assist gather and analyze information to support External Supply Quarterly Management Review provide mitigation plans for issues and risks.
• Supporting agency inspections as quality focused topic subject matter expert for all inquiries relating to external operations.
• Up to 10% travel (domestic)

Basic Qualifications:

Masters Degree and 3 years experience in GMP environment related field OR

Bachelors Degree and 5 years experience in GMP environment related field OR

High School Degree and 9 years experience in GMP environment related field

Preferred Qualifications:

Working with or at contract manufacturing or testing organizations or supporting partnerships.

Diplomacy skills and ability to assess performance and proactively identify and mitigate risks

Experience with collaborating in a cross-functional working model with support from fully-and partially dedicated resources; ability to manage through influence.

Experience with direct FDA interaction (or other regulatory agencies)

Experience writing evaluating and closing investigations CAPAs and change control records.

Must be able to work on multiple projects simultaneously and demonstrate organizational prioritization and time management proficiencies

Excellent oral and written communication skills

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

Previous experience in Quality Control Quality Assurance or Analytical Science

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 systems 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 jobs in the United States:

Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin sex age sexual orientation physical or mental disabilitygenetic 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 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 theKnow Your Rights poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

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.

Kite Pharma 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 apply via the Internal Career Opportunities portal in Workday.