{"id":2059379,"url":"https://alion.io/job/kite-pharma-quality-engineer-iii","title":"Quality Engineer III","company":{"id":1810688,"name":"Kite Pharma","domain":"kitepharma.com","url":"https://alion.io/company/kitepharma","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"middle","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Oceanside, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":107185,"max":138710,"currency":"USD","period":"year","gross":null,"usd_annual":138710},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-07T00:00:00Z","employer_posted_date":"2026-10-07","last_verified_at":"2026-10-12T13:45:52Z","board_verified":true,"closed_at":null,"days_open":5,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":5},"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 fulfil their aspirations. Join Kite and help create more tomorrows.\nJob Description\nThe Quality Engineer III serves as a subject matter expert in Computer System Validation (CSV), and Commissioning, Qualification, and Validation (CQV), Data Integrity, and Quality Risk Management. This role provides independent Quality review and oversight of qualification, validation, and compliance activities to ensure systems, facilities, equipment, and processes meet applicable regulatory and company requirements. The position partners with cross-functional teams to evaluate quality impacts, manage compliance risks, support inspection readiness, and drive continuous improvement. Applying sound technical judgment and risk-based quality principles, the Quality Engineer III helps strengthen the Quality Management System (QMS) and supports consistent, compliant, and reliable operations. The role also supports QMS activities, including change controls, risk assessments, investigations, internal and regulatory audits, and compliance assessments to maintain regulatory compliance and inspection readiness.\nJob Description\nKey Responsibilities\n Provide quality oversight for Computer System Validation (CSV), Commissioning, Qualification, and Validation (CQV) activities.\nMaintain site Data Integrity and Quality Risk Management programs to ensure compliance with regulatory and company requirements.\nReview and approve validation, qualification, and risk assessment documentation, including protocols, reports, and technical assessments.\nPerform quality impact assessments and technical evaluations for change controls, deviations, investigations, and CAPAs.\nPartner with cross-functional teams to ensure systems, equipment, and processes are qualified and maintained in compliance with applicable regulations and internal procedures.\nSupport internal audits, regulatory inspections, and compliance readiness activities.\nAnalyze quality data and metrics to identify trends, support decision making, and drive continuous improvement initiatives.\nLead or support risk assessments related to systems, facilities, materials, and manufacturing processes.\nConduct gap assessments and compliance reviews to identify and remediate regulatory or procedural risks.\nProvide technical guidance and support for validation, data integrity, and quality compliance activities across the site.\nReview technical, validation, and quality records to ensure accuracy, completeness, and regulatory compliance.\nParticipate in projects and initiatives that strengthen quality systems, compliance programs, and operational excellence.\nAdditional duties as assigned.\n\nBasic Qualifications\nBachelor's degree in Engineering, Life Sciences, Computer Science, Quality, or a related technical discipline with 5+ years of experience in Quality, Validation, Compliance, Manufacturing, or a regulated pharmaceutical/biotechnology environment; OR\nMaster's degree in a related field with 3+ years of relevant experience.\n Experience supporting Computer System Validation (CSV), Commissioning, Qualification and Validation (CQV), Quality Systems, or Data Integrity programs in a regulated environment.\nWorking knowledge of GxP, FDA, EU GMP, 21 CFR Part 11, Annex 11, and Data Integrity principles.\nExperience with quality processes including change controls, deviations, CAPAs, investigations, risk assessments, and audit support is a plus.\nAbility to review and interpret technical documentation, validation deliverables, and quality records for compliance with regulatory and company requirements.\nStrong verbal and written communication skills with the ability to effectively collaborate across Quality, Manufacturing, Engineering, Validation, and Information Technology functions.\n\nPreferred Qualifications\nExperience in the biopharmaceutical, biotechnology, cell therapy, gene therapy, or pharmaceutical manufacturing industry.\nExperience supporting regulatory inspections, internal audits, and compliance initiatives.\nFamiliarity with validation lifecycle activities for computerized systems, manufacturing equipment, and laboratory systems.\nKnowledge of quality risk management methodologies.\nAbility to develop and evolve complex quality concepts, standards, and methodologies based on sound quality engineering principles.\n Experience with electronic quality management systems (eQMS) and document management systems.\n\nThe salary range for this position is: $107,185.00 - $138,710.00. 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":9017,"description_truncated":false,"requirements":{"experience_years_min":5,"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":["Health Care","Cell & Gene Therapy","Regenerative Medicine"],"lifecycle":[{"event":"open","at":"2026-10-08T01:12:07Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 38 · green card filings: 16","filings_12m":38,"filings_prev_12m":71,"green_card_filings_12m":16,"median_offered_wage_usd":153981,"route":null,"cap_exempt":false,"checked_at":"2026-10-03T21:08:04+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.855,"p_room":1,"age_days":5,"expected_fill_days":31,"reasons":["conf:0","win:early"],"computed_at":"2026-10-12T06:55:09Z"},"pay":{"stated_usd_annual":138710,"is_top_pay":true},"html_url":"https://alion.io/job/kite-pharma-quality-engineer-iii","json_url":"https://alion.io/job/kite-pharma-quality-engineer-iii.json","meta":{"generated_at":"2026-10-12T18:49:40Z","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":30332,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-13T00:00:00Z"}},"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":1810688},"rest":"https://alion.io/mcp/rest/get_company?id=1810688"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fkite-pharma-quality-engineer-iii"},{"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%2Fkite-pharma-quality-engineer-iii"},{"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%2Fkite-pharma-quality-engineer-iii"},{"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/kite-pharma-quality-engineer-iii\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fkite-pharma-quality-engineer-iii"}]}