Senior Quality Engineer - Global Quality Systems & Processes

Overview

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.

Everyone at Kite is united by one common goal: curing cancer. We strive every day to connect this purpose to our work. Join us in making a difference!

We are seeking an experienced Quality Engineering (QE) professional to join Kite’s Global Quality Systems & Compliance team. The ideal candidate thrives in a collaborative environment that embraces continuous improvement, innovation, and risk‑based decision‑making. This individual will work cross‑functionally, demonstrate strong initiative, and communicate effectively at all organizational levels. General responsibilities include providing quality oversight of enterprise systems related to Computer System Validation (CSV), ensuring compliance with internal procedures, global regulatory requirements, and industry standards.

This position promotes Quality by Design principles by leading and/or participating in validation activities, risk assessments, system lifecycle management, and supporting Quality Management System (QMS) processes.

• Provide quality oversight for enterprise, cross‑functional, and site‑level computer system validation activities, ensuring alignment with GMP, 21 CFR Part 11, Annex 11, Data Integrity principles, and applicable industry guidance.
• Support and apply a risk‑based approach to the qualification, validation, and lifecycle management of enterprise systems.
• Ensure GMP‑relevant computer systems comply with regulations, internal procedures, and industry best practices.
• Review and assess proposed changes to validated systems, determining appropriate levels of validation, testing, and documentation required.
• Review technical documentation, workflow diagrams, test requirements, and resource needs to support validation and change‑control activities.
• Review and approve validation deliverables—including Validation Plans, Qualification Protocols, UAT Plans and Test Cases, Traceability Matrices, and Validation Summary Reports—to ensure compliance and quality standards.
• Drive innovation and process optimization related to validation and testing approaches, including adoption of automation, streamlined testing strategies, and Computer Software Assurance (CSA) principles.
• Support implementation, validation, and integration of Manufacturing Automation Systems and their interoperability with enterprise platforms.
• Serve as the validation representative on project teams, providing cGMP and CSV expertise during system design, implementation, configuration, and lifecycle activities.
• Provide quality oversight and support for new system introductions, upgrades, enhancements, and system retirement activities.
• Act as Quality Reviewer/Approver for validation activities within the QMS.
• Provide quality oversight during change control execution to ensure accurate technical impact assessments, proper documentation, and validated state maintenance.
• Support internal and external audits, regulatory inspections, and inspection‑readiness activities.
• Drive continuous improvement initiatives related to CSV, data integrity, system lifecycle management, and QMS processes.
• Support Data Integrity governance activities, including ALCOA+ compliance, DI risk assessments, periodic reviews, and system‑level controls.
• Participate in system lifecycle activities such as periodic reviews, access reviews, backup/restore…