{"id":1971237,"url":"https://alion.io/job/gilead-sciences-director-digital-quality-gmp-computer-oversight","title":"Director, Digital Quality GMP Computer Oversight","company":{"id":8130,"name":"Gilead Sciences","domain":"gilead.com","url":"https://alion.io/company/gilead","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":89,"open_postings":13,"ghost_share":0,"stale_share":0.385,"repost_share":0.077,"time_to_fill_p50_days":41,"computed_at":"2026-10-22T06:10:10Z"}},"role":"Leadership","role_family":"Leadership","seniority":"head","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Frederick, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":191250,"max":247500,"currency":"USD","period":"year","gross":null,"usd_annual":247500},"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GMP","optional":false},{"name":"Incident Management","optional":false},{"name":"Agile","optional":true}],"status":"live","first_seen_at":"2026-10-06T19:21:31Z","employer_posted_date":"2026-10-06","last_verified_at":"2026-10-22T11:20:21Z","board_verified":true,"closed_at":null,"days_open":15,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":15},"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.\nEvery 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.\nWe 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.\nJob Description\nKey Responsibilities\nValidation and assurance strategyDevelop risk-based validation or assurance plans based on intended use, GxP impact, process risk, system complexity, novelty, and supplier capability.\nDefine lifecycle deliverables, acceptance criteria, evidence expectations, roles, and approval requirements.\nApply critical thinking to focus effort on functions that could affect patient safety, product quality, record reliability, or regulatory compliance.\nUse supplier documentation and automated evidence when suitable, complete, reliable, and approved for use.\n\nLifecycle execution and oversightLead or approve GxP assessments, validation plans, user requirements, specifications, risk assessments, traceability, test strategies, test evidence, summary reports, and release decisions.\nEnsure requirements are clear, testable, risk-based, and traceable to objective evidence.\nOversee scripted, unscripted, exploratory, scenario-based, automated, and regression testing as appropriate.\nAssess deviations, defects, residual risks, and corrective actions and confirm readiness before production use.\nEnsure configuration, interfaces, data migration, reports, calculations, workflows, security roles, electronic signatures, and audit trails are adequately verified.\n\nValidated-state maintenanceProvide assurance oversight for changes, upgrades, patches, releases, incidents, periodic reviews, access reviews, backup and restore, business continuity, and system retirement.\nEvaluate change impact and regression needs using documented process and technical risk.\nMonitor validation health, overdue actions, recurring defects, supplier performance, and inspection-readiness indicators.\nEnsure archived data and records remain accessible, readable, complete, and protected throughout required retention periods.\n\nData integrity and electronic recordsAssess controls for data creation, modification, review, approval, transfer, storage, reporting, retention, and deletion.\nVerify appropriate controls for attribution, contemporaneous recording, original records, accuracy, completeness, consistency, enduring retention, and availability.\nEnsure audit-trail requirements, review procedures, record ownership, metadata, and exception handling are defined and tested.\n\nSupplier and technology assuranceLead supplier assessments and determine how supplier quality systems, development practices, testing, certifications, and service controls may be leveraged.\nEvaluate SaaS, cloud, infrastructure, platform, low-code, automation, analytics, and AI solutions for applicable GxP and data-integrity risks.\nDefine assurance expectations in quality agreements, service agreements, contracts, and support models.\nConfirm responsibilities for releases, incidents, security, backup, continuity, data return, and service termination.\n\nGovernance, standards, and inspection readinessMaintain validation standards, templates, procedures, decision trees, risk models, and training materials.\nProvide independent Quality review and approval while preserving clear accountability for process owners, system owners, IT, and suppliers.\nSupport internal audits, regulatory inspections, due diligence, and responses to observations.\nTrack and communicate validation metrics, risks, resource needs, and remediation progress to governance bodies.\n\n Leadership and capability developmentLead validation workstreams and coach validation specialists, business analysts, testers, process owners, and technical teams.\nEstimate effort, assign work, monitor deliverables, and resolve quality, schedule, and resource issues.\nPromote standardized, efficient, and evidence-based assurance practices across functions and sites.\nMonitor regulatory and industry developments and translate them into practical lifecycle controls.\n\nRequired Qualifications\nBachelor’s degree in life sciences, engineering, computer science, information systems, Quality, or a related discipline.\nAt least 8 years of experience in computer system validation, computer software assurance, Quality systems, information technology, or a related regulated function.\nExperience in a pharmaceutical, biotechnology, medical device, clinical, laboratory, manufacturing, or other regulated life-sciences environment.\nDemonstrated experience leading validation for enterprise or site-based GxP computerized systems.\nPractical knowledge of risk-based lifecycle assurance, data integrity, electronic records and signatures, and applicable validation regulations and guidance.\nExperience authoring or approving validation plans, requirements, risk assessments, traceability, test protocols or scripts, deviations, and summary reports.\nExperience with change control, incident management, periodic review, access controls, audit trails, data migration, interfaces, and system retirement.\nAbility to assess suppliers and determine appropriate use of supplier documentation and testing evidence.\nStrong technical writing, problem-solving, facilitation, project-management, and stakeholder-management skills.\nAbility to lead cross-functional teams and make documented, risk-based decisions.\nAbility to travel as needed.\nPreferred Qualifications\nAdvanced degree in life sciences, engineering, information systems, Quality, or a related discipline.\nProfessional certification related to Quality, auditing, project management, software testing, information security, or computer system validation.\nExperience with quality management, laboratory, manufacturing, enterprise resource planning, clinical, regulatory, document, learning, or data and analytics platforms.\nExperience validating SaaS, cloud, low-code, robotic process automation, advanced analytics, or AI-enabled solutions.\nExperience with agile or iterative delivery models and automated testing approaches.\nExperience supporting global deployments, regulatory inspections, remediation programs, data migrations, or complex system integrations.\nKnowledge of product management, enterprise architecture, cybersecurity, privacy, and data-governance practices.\nExperience developing validation procedures, templates, training, metrics, and communities of practice.\nRequired Knowledge and Skills\nAbility to connect intended use, process knowledge, system functionality, and patient, product, and data risks.\nAbility to distinguish GxP impact, business criticality, software complexity, and process risk and avoid using software category alone to determine validation rigor.\nKnowledge of requirements management, risk assessment, testing techniques, traceability, defect management, and objective evidence.\nKnowledge of data-integrity principles, electronic records, electronic signatures, metadata, audit trails, security, and record retention.\nUnderstanding of configurable and custom software, integrations, infrastructure, cloud service models, automation, analytics, and emerging technologies.\nAbility to review technical and Quality documentation for adequacy, consistency, traceability, and approval readiness.\nAbility to explain validation expectations clearly to technical and nontechnical stakeholders.\nSound judgment, attention to detail, independence, and the ability to manage competing priorities\nThe salary range for this position is:\nOther US Locations: $191,250.00 - $247,500.00.Bay Area: $210,375.00 - $272,250.00.Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.\nFor additional benefits information, visit:\nhttps://www.gilead.com/careers/compensation-benefits-and-wellbeing\n* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.\nFor jobs in the United States:\nGilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, geneticinformation or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact  for assistance.\nFor more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.\nNOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT\nYOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT\nGilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.\nOur environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.\nGilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.\nFor Current Gilead Employees and Contractors:\nPlease apply via the Internal Career Opportunities portal in Workday.","description_format":"text","description_chars":11716,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Life insurance"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Prescription Drugs","Oncology Therapeutics","Infectious Disease Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-06T19:21:31Z"}],"visa":[],"liveness":{"score":80,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.892,"p_room":0.9,"age_days":15,"expected_fill_days":41,"reasons":["conf:3","velocity","win:mid","comp:brand"],"computed_at":"2026-10-22T06:10:10Z"},"pay":{"stated_usd_annual":247500,"is_top_pay":true},"html_url":"https://alion.io/job/gilead-sciences-director-digital-quality-gmp-computer-oversight","json_url":"https://alion.io/job/gilead-sciences-director-digital-quality-gmp-computer-oversight.json","meta":{"generated_at":"2026-10-22T14:59:37Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":14450,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-23T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":8130},"rest":"https://alion.io/mcp/rest/get_company?id=8130"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fgilead-sciences-director-digital-quality-gmp-computer-oversight"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fgilead-sciences-director-digital-quality-gmp-computer-oversight"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fgilead-sciences-director-digital-quality-gmp-computer-oversight"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/gilead-sciences-director-digital-quality-gmp-computer-oversight\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fgilead-sciences-director-digital-quality-gmp-computer-oversight"}]}