Senior Quality Engineer I- Global Quality Systems & Processes

Kite Pharma • Frederick, MD

1d • $123,930 - $160,380

About The Position

Kite is dedicated to curing cancer through the development of innovative cancer immunotherapies, specifically pioneering personalized CAR T-cell therapies. The company aims to make significant advances in cancer therapies and evolve its business and medical science. Kite emphasizes the importance of people leaders in creating an inclusive, developed, and empowered environment for employees. The company is seeking an experienced Quality Engineering (QE) professional to join its Global Quality Systems & Compliance team. This role is for an individual who thrives in a collaborative environment, embraces continuous improvement, innovation, and risk-based decision-making, and can 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. The 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.

Requirements

• 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

Nice To Haves

• 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.

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.

Benefits

• discretionary annual bonus
• discretionary stock-based long-term incentives (eligibility may vary based on role)
• paid time off
• company-sponsored medical insurance plans
• company-sponsored dental insurance plans
• company-sponsored vision insurance plans
• company-sponsored life insurance plans

What This Job Offers

• Career Level: Senior
• Number of Employees: 501-1,000 employees