{"id":3649666,"url":"https://alion.io/job/gilead-sciences-sr-quality-engineer-i","title":"Sr Quality Engineer I","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":90,"open_postings":15,"ghost_share":0,"stale_share":0.267,"repost_share":0.2,"time_to_fill_p50_days":41,"computed_at":"2026-11-05T05:54:30Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["El Segundo, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":123930,"max":160380,"currency":"USD","period":"year","gross":null,"usd_annual":160380},"salary_estimate":null,"experience_years_min":6,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GMP","optional":false},{"name":"21 CFR Part 11","optional":true},{"name":"Microsoft Office","optional":true}],"status":"closed","first_seen_at":"2026-11-02T23:47:40Z","employer_posted_date":"2026-11-02","last_verified_at":"2026-11-05T14:57:08Z","board_verified":false,"closed_at":"2026-11-05T14:57:08Z","days_open":2,"trust":{"level":"not_scored","repost_count":null,"flags":[],"days_open":2},"description":"We’re here for one reason and one reason only - to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.\nJoin Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.\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 fulfill their aspirations. Join Kite and help create more tomorrows.\nJob Description\nEveryone at Kite is grounded by one common goal - curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in this mission!\nSr. Quality Engineer I \nWe areseekinga highly motivated individual to join us as Sr.QualityEngineer I at our El Segundo location. The ideal candidate will build strong partnerships across the site and network organizations and thrive in an environment that values teamwork, change agility, risk-based decision making, and flexibility. This role is expected to make a significant contribution to a multi-disciplinary team and requires strong written and verbal communication skills, sound quality judgment, and a high degree of personal ownership.\nThe Sr. Quality Engineer I provides Quality Engineering oversight of site processes related to validated computer systems, including Computer System Configuration Management and Computer System Validation (CSV), ensuring compliance with regulatory requirements, lifecycle procedures, and Data Integrity expectations.This position supports and leads CSV activities at the El Segundo location, reviews and approves validation documentation and risk assessments, works with project teams todeterminewhich elements require validation, and conducts impact assessments for proposed changes to computerized systems.\nThis role is expected to apply a quality-first mindset and make sound, risk-based decisions supported by clear quality and compliance rationale. The position ensures compliance with Kite procedures and all applicable regulatory requirements.\nResponsibilities:\nProvide Quality Engineering oversight for validated computer systems, ensuring compliance with cGMP, applicable regulatory requirements, lifecycle procedures, Data Integrity expectations, and intended use requirements.\n\nLead and support enterprise, cross-functional, and local computer system validation activities by providing validation approach,methodology, deliverables, and quality oversight.\n\nReview and approve validation lifecycle documentation, including Validation Plans, UAT plans, requirements and specifications, SOPs, test cases, protocols, Traceability Matrices, and Validation Summary Reports, in partnership with functional teams to ensure compliance and quality standards are met.\n\nIndependently assessvalidationlifecycle deliverables, change records, and supporting documentation for accuracy, completeness, internal consistency, and readiness for approval.\n\nEvaluate proposed changes tovalidatedcomputer systems and recommend theappropriate levelof validationrequiredfor proposed changes.\n\nProvide quality oversight for change control activities related to validated computer systems, ensuring technical and quality impact assessments are performed in a compliantmannerand systemsremainin a validated state.\n\nSupport risk-based validation of enterprise and site computer systems.\n\nIdentify, pressure-test, and clearly communicate compliance, technical, and process risks early, escalating as needed to supporttimelydecision making and effective risk mitigation.\n\nParticipate as the quality engineering representative in project team activities and computer system design discussions to ensure cGMP compliance and cross-site consistency.\n\nClearly articulate quality rationale, validation expectations, and risk-based recommendations to cross-functional stakeholders.\n\nSupport CSV projects across manufacturing and laboratory systems, including operational change management activities associated with those systems and applications.\n\nSupport implementation and deployment of manufacturing automation systems, including integration with enterprise and supporting systems.\n\nSupport new computer system introduction by serving as a technical resource and providing validation and quality expertise.\n\nApply critical thinking and sound quality judgment when evaluating ambiguous, complex, or non-routine situations.\n\nDrive actions and commitments through closure with proactive communication of status, risks, and support needs.\n\nDrive continuous improvement and innovation in computer system validation and related quality processes.\n\nSupport regulatory inspections and audits.\n\nCommunicate effectively at all levels within Quality and cross-functional across departments and sites.\n\nPerform other duties as assigned.\n\nBasic Qualifications:\nMaster’s degree and 4+ years of relevant computer systems validation experience in a cGMPenvironment\n\nOR\nBachelor’s degree and 6+ years of relevant computer systems validation experience in a cGMP environment\n\nOR\nAssociate degree and 8+ years of relevant computer systems validation experience in a cGMP environment\n\nOR\nHigh school diploma / GED and 10+ years of relevant computer systems validation experience in a cGMP environment\n\nPreferred Qualifications:\n6+ years of experience in an FDA-regulated environment with a strong understanding of cGMP requirements and risk-based validation principles.\n\n6+ years of experience in software quality assurance and/or computer system validation.\n\nStrong working knowledge of cGMP, 21 CFR Part 11, Annex 11, Data Integrity, andvalidationlifecycle requirements.\n\nProven ability to review qualification protocols and associatedvalidationlifecycle documentation, including identification and resolution of non-conformances and deviations.\n\nDemonstrated ability to apply critical thinking and problem-solving skills in complex or ambiguous situations.\n\nAbility to make sound, risk-based decisions and clearly document or explain the supporting quality rationale.\n\nStrong senseof ownership and accountability for deliverables, approvals, and follow-through.\n\nAbility to communicate proactively and effectively when facing challenges, competing priorities, or uncertainty.\n\nExcellent interpersonal, verbal, and written communication skills in a collaborative cross-functional environment.\n\nProficiencywith Microsoft Office applications.\n\nComfortable operating in a fast-paced and evolving environment.\n\nThe salary range for this position is: $123,930.00 - $160,380.00. Kite 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*.For 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.\nKite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.\nFor jobs in the United States:\nKite Pharmais 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\nKite Pharma 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.\nKite Pharmaprovides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.\nFor Current Kite Pharma Employees and Contractors:\nPlease apply via the Internal Career Opportunities portal in Workday.","description_format":"text","description_chars":10718,"description_truncated":false,"requirements":{"experience_years_min":6,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"high_school","optional":false},"security_clearance":false,"languages":[]},"benefits":["Life insurance"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Oncology Therapeutics","Infectious Disease Therapeutics"],"lifecycle":[{"event":"open","at":"2026-11-02T23:47:40Z"},{"event":"close","at":"2026-11-05T14:57:08Z"}],"visa":[],"liveness":null,"pay":{"stated_usd_annual":160380,"is_top_pay":true},"html_url":"https://alion.io/job/gilead-sciences-sr-quality-engineer-i","json_url":"https://alion.io/job/gilead-sciences-sr-quality-engineer-i.json","meta":{"generated_at":"2026-11-05T21:56:06Z","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":2332,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-06T00:00:00Z"}},"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-sr-quality-engineer-i"},{"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-sr-quality-engineer-i"},{"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-sr-quality-engineer-i"},{"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-sr-quality-engineer-i\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fgilead-sciences-sr-quality-engineer-i"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3649666}},{"tool":"search_jobs","arguments":{"company":"gilead.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3649666},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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