Quality Engineer III

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About the 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 The Quality Engineer III serves as a subject matter expert in Computer System Validation (CSV), and Commissioning, Qualification, and Validation ( CQV), Data Integrity, and Quality Risk Management. This role provides independent Quality review and oversight of qualification, validation, and compliance activities to ensure systems, facilities, equipment, and processes meet applicable regulatory and company requirements. The position partners with cross-functional teams to evaluate quality impacts, manage compliance risks, support inspection readiness, and drive continuous improvement. Applying sound technical judgment and risk-based quality principles, the Quality Engineer III helps strengthen the Quality Management System (QMS) and supports consistent, compliant, and reliable operations. The role also supports QMS activities, including change controls, risk assessments, investigations, internal and regulatory audits, and compliance assessments to maintain regulatory compliance and inspection readiness.     Job Description Key Responsibilities • • Provide quality oversight for Computer System Validation (CSV), Commissioning, Qualification, and Validation (CQV) activities. • Maintain site Data Integrity and Quality Risk Management programs to ensure compliance with regulatory and company requirements. • Review and approve validation, qualification, and risk assessment documentation, including protocols, reports, and technical assessments. • Perform quality impact assessments and technical evaluations for change controls, deviations, investigations, and CAPAs. • Partner with cross-functional teams to ensure systems, equipment, and processes are qualified and maintained in compliance with applicable regulations and internal procedures. • Support internal audits, regulatory inspections, and compliance readiness activities. • Analyze quality data and metrics to identify trends, support decision making, and drive continuous improvement initiatives. • Lead or support risk assessments related to systems, facilities, materials, and manufacturing processes. • Conduct gap assessments and compliance reviews to identify and remediate regulatory or procedural risks. • Provide technical guidance and support for validation, data integrity, and quality compliance activities across the site. • Review technical, validation, and quality records to ensure accuracy, completeness, and regulatory compliance. • Participate in projects and initiatives that strengthen quality systems, compliance programs, and operational excellence. • Additional duties as assigned.   Basic Qualifications • • Bachelor's degree in Engineering, Life Sciences, Computer Science, Quality, or a related technical discipline with 5+ years of experience in Quality, Validation, Compliance, Manufacturing, or a regulated pharmaceutical/biotechnology environment; OR • Master's degree in a related field with 3+ years of relevant experi

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