{"id":3508938,"url":"https://alion.io/job/exelixis-qa-systems-and-process-manager","title":"QA Systems and Process Manager","company":{"id":1917987,"name":"Exelixis","domain":"exelixis.com","url":"https://alion.io/company/exelixis-com","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":"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":["Alameda, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":145000,"max":184000,"currency":"USD","period":"year","gross":null,"usd_annual":184000},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 11","optional":false},{"name":"CAPA","optional":false},{"name":"GLP","optional":false},{"name":"Good Clinical Practice","optional":false}],"status":"live","first_seen_at":"2026-10-29T00:00:00Z","employer_posted_date":"2026-10-29","last_verified_at":"2026-11-04T04:27:17Z","board_verified":true,"closed_at":null,"days_open":6,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":6},"description":"SUMMARY/JOB PURPOSE\nQA Process and Systems Manager is responsible for quality assurance oversight of risk-based validation and lifecycle compliance of GxP computerized systems. This role oversees end-to-end lifecycle validation state of computerized systems, from initial assessment and implementation through operation, periodic review, changes, and system retirement. The QA Process and Systems Manager partners cross-functionally with IT, system owners, business owners, operational teams and external vendors and service providers to ensure data integrity, audit and inspection readiness, continuous improvement, and compliance.\nESSENTIAL DUTIES/RESPONSIBILITIES\nProvide independent, risk-based QA oversight of GxP regulated computerized systems for IT, Clinical Data Management and other functional systems, as applicable\nReview and approve validation deliverables (risk assessments, validation plans and tests, user acceptance tests, test evidence, summary reports, change controls, deviations)\nAuthor and execute of CSV implementation plans in a timely, as requested\nDevelop solutions and manage project/change timelines, as requested\nCreate and run reports, track follow-up actions and ensure data quality and compliance\nEvaluate system incidents, deviations and CAPAs to maintain a validated state\nIdentify and escalate compliance risks\nReview and approve CSV change controls, and continuous improvement initiatives\nGenerate metrics to support business goals\nManage updates to business guidances and user reference documentation\nContinuously improve monitoring, user issues and deliver better value to the customer\nSupport activities for internal and external audits/inspections\nProvide technical expertise to enable the transformation from Computer System Validation (CVS) to Computer software Assurance (CSA)\nDrive issues to resolution\nPerforms other duties as assigned\nComplies with all policies and standards\nSUPERVISORY RESPONSIBILITIES\nNo supervisory responsibilities\nEDUCATION/EXPERIENCE/KNOWLEDGE/SKILLS & ABILITIES\nEducation\nBachelor's degree in science or related field and 7 years of related experience; or,\nEquivalent combination of education and experience.\nExperience\n5+ years of experience working on GxP validated applications in a pharmaceutical or regulated environment.\nExperience and knowledge of the quality and regulatory business processes.\nDirect hands-on experience implementing GxP computerized systems and maintaining validated state.\nKnowledge, Skills and Abilities\nRequired:\nStrong process improvement skills and orientation\nProven business and technology skills, with proven success in providing customer-oriented technology solutions environment\nExcellent proven communication (verbal and written) and presentation skills, interacting with user and technical communities\nAbility to communicate ideas in both technical and user-friendly language\nStrong team player with collaborative approach to work\nDeep understanding of applicable regulatory guidelines (21 CFR Part 11, EU Annex 11, ICH GCP/GLP, data integrity principles, etc.)\nGeneral knowledge of database and computer networking\nWorking knowledge/experience with SaaS systems\nAbility to work with confidential data\nPrioritizes and drives for results\nPreferred:\nExperience or understanding of computer software assurance\nTravel Requirements\n5% Up to 5% travel time\nLocation: Alameda, CA\n\nRange for this position: $145,000 - $184,000\n\nThe base pay offered will take into account job-related knowledge, skills, experience and internal equity, among other factors.In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.\nIf you have a disability and need an accommodation in relation to the recruiting process, please email us at: .\nWORKING CONDITIONS:\nOur office is a modern space that fosters collaboration and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.\nDISCLAIMER:\nThe preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.\nWe are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.","description_format":"text","description_chars":5330,"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":["401k plan","Equity"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Oncology Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-30T06:33:22Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 33 · green card filings: 10","filings_12m":33,"filings_prev_12m":37,"green_card_filings_12m":10,"median_offered_wage_usd":192733,"route":null,"cap_exempt":false,"checked_at":"2026-10-29T16:27:21+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":90,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.903,"p_room":1,"age_days":5,"expected_fill_days":20,"reasons":["conf:9","velocity","win:early"],"computed_at":"2026-11-03T05:54:40Z"},"pay":{"stated_usd_annual":184000,"is_top_pay":true},"html_url":"https://alion.io/job/exelixis-qa-systems-and-process-manager","json_url":"https://alion.io/job/exelixis-qa-systems-and-process-manager.json","meta":{"generated_at":"2026-11-04T06:09:48Z","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":9572,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-05T00:00:00Z"}},"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":1917987},"rest":"https://alion.io/mcp/rest/get_company?id=1917987"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fexelixis-qa-systems-and-process-manager"},{"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%2Fexelixis-qa-systems-and-process-manager"},{"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%2Fexelixis-qa-systems-and-process-manager"},{"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/exelixis-qa-systems-and-process-manager\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fexelixis-qa-systems-and-process-manager"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3508938}},{"tool":"search_jobs","arguments":{"company":"exelixis.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3508938},"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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