Director of Digital Quality & GxP Validation

Gilead Sciences Inc.; La Verne (CA); In loco; USD 191.000 - 272.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical, dental, vision and life-ins.

Descrizione del lavoro

Gilead Sciences Inc. in the United States seeks an experienced Validation and Quality Assurance professional to lead lifecycle validation across GxP computerized systems.

You will define strategies, deliver evidence-based requirements, and oversee testing, changes, and release decisions to ensure patient safety and product quality. Key responsibilities include leading assessments, risk-based planning, and supplier evaluations, with focus on data integrity, electronic records, and regulatory

Competenze

• 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 travel as needed.

Mansioni

• 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.
• 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.
• Lead 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.
• Provide 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.
• Assess 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.
• Lead 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.
• Maintain 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.

Conoscenze

GxP validation

Data integrity

Risk-based thinking

Regulatory compliance

Technical writing

Project management

Cross-functional teamwork

Travel flexibility

Formazione

Bachelor's degree in life sciences/engineering/CS/IS/Quality

Advanced degree (preferred)

Quality/certification credentials

Descrizione del lavoro

Gilead Sciences Inc. in the United States seeks an experienced Validation and Quality Assurance professional to lead lifecycle validation across GxP computerized systems.

You will define strategies, deliver evidence-based requirements, and oversee testing, changes, and release decisions to ensure patient safety and product quality. Key responsibilities include leading assessments, risk-based planning, and supplier evaluations, with focus on data integrity, electronic records, and regulatory