Quality Assurance Specialist Iii- External Quality

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site 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.

We are seeking a highly motivated individual contributor to join us as a QA Specialist III within External Quality embedded within Kite's Product and Distribution 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 Kite's Global Technical Operations organization (e.g. Process and Analytical Development, MSAT, Regulatory, Quality, Manufacturing, and Supply Chain), as well as international partners, multiple CMO/CDMOs and CTLs. The ideal candidate will have excellent quality and compliance background (Biologics/Drug/GMP regulation, ATMP specific regulation), technical skills (knowledge of one or more of the following: cell therapy, viral vector, DNA/RNA production and testing operations); and understanding of the drug development life cycle.

This position will be based at Kite's headquarters in Santa Monica, CA.

Responsibilities of the QA Specialist III include:

• Quality oversight and 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 Kite's CMOs.

• 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 25% travel (both domestic and international)

Basic Qualifications:

• Master's Degree and 3+ years' experience in GMP environment related field OR

• Bachelor's 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) required

• 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.

Does this sound like you? If so, apply today!

The salary range for this position is: $104,805.00 - $135,630.00. 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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For Current Kite Pharma Employees and Contractors:

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