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 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. J-18808-Ljbffr