Senior Quality Engineer – Global Quality Systems, Processes

Gilead Sciences

Quality Engineer providing oversight on Computer System Validation at Kite Pharma. Facilitating compliance, innovation, and quality assurance in cancer treatment developments.

Posted 4/22/2026full-timeCalifornia, Maryland • 🇺🇸 United StatesSenior💰 $123,930 - $160,380 per yearWebsite

Tech Stack

Tools & technologies

CloudCyber SecurityERP

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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
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.

Benefits

Comp & perks

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

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

computer system validationrisk-based validationquality assurancevalidation documentation reviewlifecycle managementdata integrityautomationdisaster recovery validationsupplier qualificationcybersecurity controls

Soft Skills

critical thinkingtroubleshootingproblem-solvingself-motivatedadaptableinterpersonal communicationverbal communicationwritten communicationcollaborative problem-solvingtransparency