{"id":2681825,"url":"https://alion.io/job/novartis-manager-quality-systems","title":"Manager, Quality Systems","company":{"id":5824,"name":"Novartis","domain":"novartis.com","url":"https://alion.io/company/novartis","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":86,"open_postings":63,"ghost_share":0,"stale_share":0.556,"repost_share":0.032,"time_to_fill_p50_days":35,"computed_at":"2026-10-17T05:46:00Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Carlsbad, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":114100,"max":211900,"currency":"USD","period":"year","gross":null,"usd_annual":211900},"salary_estimate":null,"experience_years_min":7,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[{"name":"CAPA","optional":false},{"name":"GCP","optional":false}],"status":"live","first_seen_at":"2026-10-15T00:00:00Z","employer_posted_date":"2026-10-15","last_verified_at":"2026-10-17T07:14:44Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"description":"Job Description Summary\nLocation: Carlsbad, CaliforniaThe Manager, Quality Systems will serve as a Quality subject matter expert, providing oversight to support commercialization readiness and the continued effectiveness of the Quality Management System. This role will develop and maintain statistically sound, risk-based approaches for evaluating quality data, identify emerging trends and risks, and translate regulatory requirements and quality insights into actionable recommendations. The position will also lead cross-functional quality and regulatory training, support CAPA/Issues and Change Control activities, manage the Medical Device Reporting program, and provide Quality guidance during investigations and troubleshooting within a regulated bioanalytical laboratory environment.\n#LI-OnSite\nJob Description\nKey Responsibilities\nProvide Quality oversight to support commercialization readiness, including applicable processes and procedures for the commercialization of IVD devices.\nProvide Quality oversight, review, and approval of statistical frameworks, programs, and deliverables, including manufacturing QC programs and risk assessments.\nManage the Medical Device Event Reporting process and support CAPA/Issues and Change Control programs in accordance with internal procedures and applicable regulatory requirements.\nEvaluate quality events, including deviations, CAPAs, complaints, audit findings, OOS, NCMR, and OOR, providing guidance on risk assessment, impact, immediate remediation, and preventive actions.\nAnalyze quality-related data to identify issues and emerging trends and provide recommendations to management that support the effectiveness and continuous improvement of the Quality Management System.\nDevelop and deliver enterprise-wide GxP, CLIA, IVD Manufacturing, ISO, and GCLP training to ensure compliance with regulatory requirements.\nSupport clinical laboratory compliance with applicable accreditation requirements and support internal, sponsor, and regulatory audits, including managing assigned audit observations through resolution.\nMaintain current knowledge of applicable industry standards and regulatory requirements, including IVDR, MDCG 2024-4, ISO, CLIA/CAP, QSR, GCP/GCLP, cGMP, and ICH, and promote their consistent application across Quality activities and training.\nEssential Requirements\nBS in engineering, medical technology, biological sciences, or related field.\nMinimum of seven (7) years progressively responsible experience in a related Quality Assurance role in a regulated environment.\nExperience, understanding, and familiarity with regulatory and compliance requirements and guidelines, including GxP, Part 11, ICH, ISO, CLIA/CAP, IVDR, and QSR.\nDemonstrated ability to understand and apply risk-based practices, with process analysis and root cause analysis experience and the ability to establish improved processes based on outcomes.\nExperience developing procedures and training, with strong communication and collaboration skills and the ability to present data and substantiate approaches before audiences and inspectors.\nAbility to work as an independent contributor, identifying and executing continuous improvement opportunities.\nDesirable Requirements\nExperience with commercialization or commercialized IVD products\nExperience with statistics or statistical frameworks, assay validation, or QC Trending\nThe salary for this position is expected to range between $114,100 and $211,900 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.\nTo learn more about the culture, rewards and benefits we offer our people click here.\nEEO Statement:\nThe Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.\nAccessibility and reasonable accommodations\nThe Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to  call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.\nSalary Range\n$114,100.00 - $211,900.00Skills Desired\nAudits Compliance, cGMP Compliance, Collaboration, Communication, Data Integrity, Decision Making, Internal Auditing, Managing Ambiguity, Problem Solving, Quality Assurance (QA), Quality Auditing, Quality Compliance, Quality Management, Quality Management System Implementation, Quality Management Systems (QMS), Regulatory Compliance, Risk Management, Validation Activities","description_format":"text","description_chars":5687,"description_truncated":false,"requirements":{"experience_years_min":7,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Equity"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Oncology Therapeutics","Neurology & CNS Therapeutics","Immunology & Inflammation Therapeutics","Cardiometabolic Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-16T06:36:39Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 8 · green card filings: 2","filings_12m":8,"filings_prev_12m":18,"green_card_filings_12m":2,"median_offered_wage_usd":146500,"route":null,"cap_exempt":false,"checked_at":"2026-10-15T11:24:14+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":63,"band":"ok","label":"Likely open","p_open":1,"p_active":0.632,"p_room":1,"age_days":2,"expected_fill_days":35,"reasons":["conf:3","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-10-17T05:46:00Z"},"pay":{"stated_usd_annual":211900,"is_top_pay":true},"html_url":"https://alion.io/job/novartis-manager-quality-systems","json_url":"https://alion.io/job/novartis-manager-quality-systems.json","meta":{"generated_at":"2026-10-17T14:13:38Z","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":"assistant_verified","counted_by":"address","units_charged":1,"used_today":2362,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-18T00:00:00Z"}},"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":5824},"rest":"https://alion.io/mcp/rest/get_company?id=5824"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fnovartis-manager-quality-systems"},{"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%2Fnovartis-manager-quality-systems"},{"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%2Fnovartis-manager-quality-systems"},{"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/novartis-manager-quality-systems\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fnovartis-manager-quality-systems"}]}