Sr Quality Engineer I

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 fulfill 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