Job DescriptionEveryone 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.
Responsibilities- 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.
- 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 testing, disaster recovery validation, and retirement planning.
- Support supplier qualification activities for GxP-relevant cloud, SaaS, or vendor-managed systems, including participation in vendor audits.
- Collaborate with IT Security to ensure appropriate cybersecurity controls for GxP systems (e.g., identity management, audit trails, vulnerability assessments).
- Contribute to development, review, and improvement of procedures, work instructions, templates, and training related to CSV, data integrity, and GxP system governance.
- Partner with IT and business owners to support service levels, incident management, deviation handling, and problem resolution in alignment with ITIL principles.
- Communicate effectively with functional teams, leadership, and global partners to ensure alignment, transparency, and collaborative problem-solving.
- Perform other duties as assigned.
Basic Qualifications - Master's degree and 4+ years of Computer Systems experience
OR
- Bachelor's degree and 6+ years of Computer Systems experience
OR
- Associate degree and 8+ years of Computer Systems experience
OR
- High School Diploma/GED and 10+ years of Computer Systems experience
Preferred Qualifications - Experience in software quality assurance or quality oversight roles within a biopharmaceutical environment
- 5+ years in an FDA-regulated environment with strong understanding of cGxP standards and risk-based validation principles.
- Demonstrated ability to review validation documentation, lifecycle deliverables, deviations, and non-conformances.
- Strong critical thinking, troubleshooting, and problem-solving skills.
- Self-motivated and adaptable, with willingness to take on responsibilities beyond initial job scope.
- Prior experience with enterprise systems (e.g., ERP, LIMS, MES, QMS).
- Excellent interpersonal, verbal, and written communication skills.
- Comfortable working in a fast-paced and dynamic environment.
The salary range for this position is: $123,930.00 - $160,380.00. 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*.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.
