Director, Digital Quality GMP 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 lifecycle assurance, GxP compliance, and validation of computerized systems within regulated environments. Proficient in leading cross-functional teams, managing validation processes, and ensuring data integrity and compliance with applicable regulations.

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 MigrationTraceabilityDefect ManagementElectronic RecordsAudit Trails

Soft Skills

Technical WritingProblem-SolvingProject ManagementStakeholder ManagementAttention to Detail

Tools & Technologies

SaaS SolutionsCloud ServicesAutomation ToolsAnalytics PlatformsConfigurable Software

Industry Keywords

PharmaceuticalBiotechnologyMedical DeviceClinicalLaboratoryManufacturingRegulated Life-SciencesQuality SystemsElectronic SignaturesRegulatory Inspections

Tech Stack

Tools & technologies

Cloud

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
Lead or approve GxP assessments, validation plans, user 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 readiness before production use
Ensure configuration, interfaces, data migration, reports, calculations, workflows, security roles, electronic signatures, and audit trails are adequately verified
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
Lead supplier assessments and 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
Maintain validation standards, templates, procedures, decision trees, risk models, and training materials
Provide independent Quality review and approval and 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
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 ability to manage competing priorities

Benefits

Comp & perks

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