Sr. Quality Engineer I

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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

We are seeking a highly motivated individual to join us as Sr. Quality Engineer I at our El Segundo location. The ideal candidate will interface and build strong partnerships with other parts of site as well as Network organizations. This position must excel in an environment that embraces teamwork, change, risk-based decision making and flexibility. This role is expected to make a significant contribution to a multi-discipline team, must be self-motivated to take actions, and have excellent written and verbal communication skills.

Job responsibilities include QE oversight of site processes related to cGMP such as Computer System Configuration Management and Computer System Validation (CSV), ensuring compliance with regulatory requirements, and Lifecycle procedures with Data Integrity requirements. This position will provide management of CSV validation activities at the El Segundo Location, as well as support for CSV validations across kite network, lead the review and approval of validation documentation, risk assessments, work with project teams to determine which elements should be validated and conduct impact assessment of proposed changes to computerized systems.

The position will ensure compliance with Kite’s procedures and all applicable regulatory guidelines.

Responsibilities:

• Support enterprise, cross functional and local computer systems validation activities, in providing approach, methodology and deliverables in compliance with GMP, 21 CFR Part 11, Annex 11 and Data Integrity.
• Support risk-based approach to qualification of enterprise and computer systems.
• Ensure that GMP computer systems meet intended uses and comply with applicable regulations, current industry practices, and Kite policies and procedures. CSV projects will include manufacturing and lab systems, and steady state activities around these systems and its applications.
• Evaluate proposed changes to validated computer systems and recommend level of validation activities required
• Review technical communications, document flow, testing requirements, and resources necessary to complete the validation of a system.
• Review and Approve validation documents (Validation plan, Qualification and UAT plans and test cases, Traceability Matrix and Validation Summary Reports) with functional teams, ensuring the documentation meets compliance requirements and quality standards.
• Drive innovation and streamline overall testing processes.
• Support implementation and deployment of Manufacturing Automation Systems for integration with Enterprise systems
• Participate as the validation representative in project team activities and process design to ensure cGMP compliance and cross-site consistency within the validation program.
• Support new system introduction by serving as a technical resource and providing technical expertise.
• Act as the Quality Reviewer/Approver for validation activities
• Providing quality oversight in change control activities to ensure technical and document impact assessments are performed in a compliant manner and the regulated systems are maintained in a validated state.
• Support regulatory inspections and audits.
• Drive continuous process improvement around computer system validation
• Communicate effectively at all levels within Quality, as well as cross functionally with departments and sites
• Perform other duties as assigned.

Basic Qualifications:

• PHD/PharmD OR
• Master’s and 4+ years of Computer Systems experience OR
• Bachelor’s and 6+ years of Computer Systems experience OR

Preferred Qualifications:

• Work experience in software quality assurance.
• 5+ years’ experience in FDA regulated environment with strong understanding of cGxP standards and risk-based validation.
• Proven track record to review qualification protocols and associated validation lifecycle documentation, including identification and resolution of non-conformances /deviations.
• Ability to think critically and utilize troubleshooting and problem-solving skills.
• Self-motivated and willing to accept temporary responsibilities outside of initial job description.
• Well-developed computer skills and fluent with Microsoft office applications.
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
• Comfortable in a fast-paced company and ambiguous environment

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

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$IND123

The salary range for this position is: $121,125.00 - $156,750.00. 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.