Director, Digital Quality GMP Computer Oversight

Job description

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. 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 Gilead and help create possible, together. Job Description Key ResponsibilitiesValidation and assurance strategyDevelop risk-based validation or assurance plans based on intended use, GxP impact, process risk, system complexity, novelty, and supplier capability. Define lifecycle deliverables, acceptance criteria, evidence expectations, roles, and approval requirements. Apply critical thinking to focus effort on functions that could affect patient safety, product quality, record reliability, or regulatory compliance. Use supplier documentation and automated evidence when suitable, complete, reliable, and approved for use. Lifecycle execution and oversightLead or approve GxP assessments, validation plans, user requirements, specifications, risk assessments, traceability, test strategies, test evidence, summary reports, and release decisions. Ensure requirements are clear, testable, risk-based, and traceable to objective evidence. Oversee scripted, unscripted, exploratory, scenario-based, automated, and regression testing as appropriate. Assess deviations, defects, residual risks, and corrective actions and confirm readiness before production use. Ensure configuration, interfaces, data migration, reports, calculations, workflows, security roles, electronic signatures, and audit trails are adequately verified. Validated-state maintenanceProvide assurance oversight for changes, upgrades, patches, releases, incidents, periodic reviews, access reviews, backup and restore, business continuity, and system retirement. Evaluate change impact and regression needs using documented process and technical risk. Monitor validation health, overdue actions, recurring defects, supplier performance, and inspection-readiness indicators. Ensure archived data and records remain accessible, readable, complete, and protected throughout required retention periods. Data integrity and electronic recordsAssess controls for data creation, modification, review, approval, transfer, storage, reporting, retention, and deletion. Verify appropriate controls for attribution, contemporaneous recording, original records, accuracy, completeness, consistency, enduring retention, and availability. Ensure audit-trail requirements, review procedures, record ownership, metadata, and exception handling are defined and tested. Supplier and technology assuranceLead supplier assessments and determine how supplier quality systems, development practices, testing, certifications, and service controls may be leveraged. Evaluate SaaS, cloud, infrastructure, platform, low-code, automation, analytics, and AI solutions for applicable GxP and data-integrity risks. Define assurance expectations in quality agreements, service agreements, contracts, and support models. Confirm responsibilities for releases, incidents, security, backup, continuity, data return, and service termination. Governance, standards, and inspection readinessMaintain validation standards, templates, procedures, decision trees, risk models, and training materials. Provide independent Quality review and approval while preserving clear accountability for process owners, system owners, IT, and suppliers. Support internal audits, regulatory inspections, due diligence, and responses to observations. Track and communicate validation metrics, risks, resource needs, and remediation progress to governance bodies. Leadership and capability developmentLead validation workstreams and coach validation specialists, business analysts, testers, process owners, and technical teams. Estimate effort, assign work, monitor deliverables, and resolve quality, schedule, and resource issues. Promote standardized, efficient, and evidence-based assurance practices across functions and sites. Monitor regulatory and industry developments and translate them into practical lifecycle controls. Required QualificationsBachelor’s degree in life sciences, engineering, computer science, information systems, Quality, or a related discipline. At least 8 years of experience in computer system validation, computer software assurance, Quality systems, information technology, or a related regulated function. Experience in a pharmaceutical, biotechnology, medical device, clinical, laboratory, manufacturing, or other regulated life-sciences environment. Demonstrated experience leading validation for enterprise or site-based GxP computerized systems. Practical knowledge of risk-based lifecycle assurance, data integrity, electronic records and signatures, and applicable validation regulations and guidance. Experience authoring or approving validation plans, requirements, risk assessments, traceability, test protocols or scripts, deviations, and summary reports. Experience with change control, incident management, periodic review, access controls, audit trails, data migration, interfaces, and system retirement. Ability to assess suppliers and determine appropriate use of supplier documentation and testing evidence. Strong technical writing, problem-solving, facilitation, project-management, and stakeholder-management skills. Ability to lead cross-functional teams and make documented, risk-based decisions. Ability to travel as needed. Preferred QualificationsAdvanced degree in life sciences, engineering, information systems, Quality, or a related discipline. Professional certification related to Quality, auditing, project management, software testing, information security, or computer system validation. Experience with quality management, laboratory, manufacturing, enterprise resource planning, clinical, regulatory, document, learning, or data and analytics platforms. Experience validating SaaS, cloud, low-code, robotic process automation, advanced analytics, or AI-enabled solutions. Experience with agile or iterative delivery models and automated testing approaches. Experience supporting global deployments, regulatory inspections, remediation programs, data migrations, or complex system integrations. Knowledge of product management, enterprise architecture, cybersecurity, privacy, and data-governance practices. Experience developing validation procedures, templates, training, metrics, and communities of practice. Required Knowledge and SkillsAbility to connect intended use, process knowledge, system functionality, and patient, product, and data risks. Ability to distinguish GxP impact, business criticality, software complexity, and process risk and avoid using software category alone to determine validation rigor. Knowledge of requirements management, risk assessment, testing techniques, traceability, defect management, and objective evidence. Knowledge of data-integrity principles, electronic records, electronic signatures, metadata, audit trails, security, and record retention. Understanding of configurable and custom software, integrations, infrastructure, cloud service models, automation