Director, Digital Quality GMP Computer Oversight

Gilead Sciences

. Develop risk-based validation or assurance plans based on intended use, GxP impact, process risk, system complexity, novelty, and supplier capability .

Posted 10/28/2026full-timeUnited StatesLead💰 $191,250 - $272,250 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in risk-based validation and assurance practices, ensuring compliance with GxP regulations and maintaining data integrity across systems. Proficient in leading cross-functional teams and managing validation processes for computerized systems in regulated environments.

Highest-signal resume keywords

Computer System ValidationGxP ComplianceRisk-Based Lifecycle AssuranceValidation Plans AuthoringData Integrity Principles

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Validation PlansRisk AssessmentsTest ProtocolsChange ControlIncident ManagementData MigrationAudit TrailsElectronic RecordsTesting TechniquesTraceability

Soft Skills

Technical WritingProblem-SolvingFacilitationProject ManagementStakeholder Management

Tools & Technologies

SaaS SolutionsCloud TechnologiesAutomation ToolsAnalytics PlatformsRobotic Process Automation

Certifications & Qualifications

Quality CertificationAuditing CertificationProject Management CertificationSoftware Testing CertificationInformation Security Certification

Industry Keywords

PharmaceuticalBiotechnologyMedical DeviceClinicalLaboratoryManufacturingRegulated Life SciencesQuality SystemsEnterprise Resource PlanningData Governance

Tech Stack

Tools & technologies

CloudCyber SecurityRPA

About the role

Key responsibilities & impact

Develop 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
Focus assurance efforts on functions affecting patient safety, product quality, record reliability, or regulatory compliance
Lead or approve GxP assessments, validation plans, requirements, specifications, risk assessments, traceability, test strategies, test evidence, summary reports, and release decisions
Oversee scripted, unscripted, exploratory, scenario-based, automated, and regression testing
Assess deviations, defects, residual risks, and corrective actions and confirm production readiness
Verify configuration, interfaces, data migration, reports, calculations, workflows, security roles, electronic signatures, and audit trails
Provide assurance oversight for changes, upgrades, patches, releases, incidents, periodic reviews, access reviews, backup and restore, business continuity, and system retirement
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
Assess controls for data creation, modification, review, approval, transfer, storage, reporting, retention, and deletion
Ensure audit-trail requirements, review procedures, record ownership, metadata, and exception handling are defined and tested
Lead supplier assessments and evaluate supplier quality systems, development practices, testing, certifications, and service controls
Evaluate SaaS, cloud, infrastructure, platform, low-code, automation, analytics, and AI solutions for 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
Maintain validation standards, templates, procedures, decision trees, risk models, and training materials
Provide independent Quality review and approval while preserving 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
Lead 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

Requirements

What you’ll need

Bachelor’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: Advanced degree in life sciences, engineering, information systems, Quality, or a related discipline
Preferred: Professional certification related to Quality, auditing, project management, software testing, information security, or computer system validation
Preferred: Experience with quality management, laboratory, manufacturing, enterprise resource planning, clinical, regulatory, document, learning, or data and analytics platforms
Preferred: Experience validating SaaS, cloud, low-code, robotic process automation, advanced analytics, or AI-enabled solutions
Preferred: Experience with agile or iterative delivery models and automated testing approaches
Preferred: Experience supporting global deployments, regulatory inspections, remediation programs, data migrations, or complex system integrations
Preferred: Knowledge of product management, enterprise architecture, cybersecurity, privacy, and data-governance practices
Preferred: Experience developing validation procedures, templates, training, metrics, and communities of practice
Ability 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
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, analytics, and emerging technologies
Ability to review technical and Quality documentation for adequacy, consistency, traceability, and approval readiness
Ability to explain validation expectations clearly to technical and nontechnical stakeholders
Sound judgment, attention to detail, independence, and the ability to manage competing priorities

Benefits

Comp & perks

Discretionary annual bonus eligibility
Discretionary stock-based long-term incentives eligibility
Paid time off
Company-sponsored medical insurance
Company-sponsored dental insurance
Company-sponsored vision insurance
Company-sponsored life insurance