Sr Quality Engineer I

About this role

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

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 this mission! Sr. Quality Engineer I   

We are   seeking   a highly motivated individual to join us as Sr. Quality   Engineer I  at our El Segundo  location. The ideal candidate will build strong partnerships across the site and network organizations and thrive in an environment that values teamwork, change agility, risk-based decision making, and flexibility. This role is expected to make a significant contribution to a multi-disciplinary team and requires strong written and verbal communication skills, sound quality judgment, and a high degree of personal ownership.  

The Sr. Quality Engineer I provides Quality Engineering oversight of site processes related to validated computer systems, including Computer System Configuration Management and Computer System Validation (CSV), ensuring compliance with regulatory requirements, lifecycle procedures, and Data Integrity expectations.   This position supports and leads CSV activities at the El Segundo location, reviews and approves validation documentation and risk assessments, works with project teams to   determine   which elements require validation, and conducts impact assessments for proposed changes to computerized systems.  

This role is expected to apply a quality-first mindset and make sound, risk-based decisions supported by clear quality and compliance rationale. The position ensures compliance with Kite procedures and all applicable regulatory requirements.  

Responsibilities:  

• Provide Quality Engineering oversight for validated computer systems, ensuring compliance with cGMP, applicable regulatory requirements, lifecycle procedures, Data Integrity expectations, and intended use requirements.  

• Lead and support enterprise, cross-functional, and local computer system validation activities by providing validation approach,   methodology , deliverables, and quality oversight.  

• Review and approve validation lifecycle documentation, including Validation Plans, UAT plans, requirements and specifications, SOPs, test cases, protocols, Traceability Matrices, and Validation Summary Reports, in partnership with functional teams to ensure compliance and quality standards are met.  

• Independently assess   validation   lifecycle deliverables, change records, and supporting documentation for accuracy, completeness, internal consistency, and readiness for approval.  

• Evaluate proposed changes to   validated   computer systems and recommend the   appropriate level   of validation   required   for proposed changes.  

• Provide quality oversight for change control activities related to validated computer systems, ensuring technical and quality impact assessments are performed in a compliant   manner   and systems   remain   in a validated state.  

• Support risk-based validation of enterprise and site computer systems.  

• Identify , pressure-test, and clearly communicate compliance, technical, and process risks early, escalating as needed to support   timely   decision making and effective risk mitigation.  

• Participate as the quality engineering representative in project team activities and computer system design discussions to ensure cGMP compliance and cross-site consistency.  

• Clearly articulate quality rationale, validation expectations, and risk-based recommendations to cross-functional stakeholders.  

• Support CSV projects across manufacturing and laboratory systems, including operational change management activities associated with those systems and applications.  

• Support implementation and deployment of manufacturing automation systems, including integration with enterprise and supporting systems.  

• Support new computer system introduction by serving as a technical resource and providing validation and quality expertise.  

• Apply critical thinking and sound quality judgment when evaluating ambiguous, complex, or non-routine situations.  

• Drive actions and commitments through closure with proactive communication of status, risks, and support needs.  

• Drive continuous improvement and innovation in computer system validation and related quality processes.  

• Support regulatory inspections and audits.  

• Communicate effectively at all levels within Quality and cross-functional across departments and sites.  

• Perform other duties as assigned.  

Basic Qualifications:  

• Master’s degree and 4+ years of relevant computer systems validation experience in a cGMP   environment

OR  

• Bachelor’s degree and 6+ years of relevant computer systems validation experience in a cGMP environment

OR  

• Associate degree and 8+ years of relevant computer systems validation experience in a cGMP environment

OR  

• High school diploma / GED and 10+ years of relevant computer systems validation experience in a cGMP environment  

Preferred Qualifications:  

• 6+ years of experience in an FDA-regulated environment with a strong understanding of cG M P requirements and risk-based validation pri

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