{"id":762769,"url":"https://alion.io/job/immunome-director-quality-operations","title":"Director, Quality Operations","company":{"id":3828286,"name":"Immunome","domain":"immunome.com","url":"https://alion.io/company/immunome","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":{"grade":"A","score":88,"open_postings":4,"ghost_share":0,"stale_share":0.5,"repost_share":0,"time_to_fill_p50_days":38,"computed_at":"2026-10-28T05:59:10Z"}},"role":"Aerospace","role_family":"Aerospace","seniority":"head","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Bothell, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":212149,"max":239998,"currency":"USD","period":"year","gross":null,"usd_annual":239998},"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-07-23T23:35:27Z","employer_posted_date":"2026-07-23","last_verified_at":"2026-10-28T11:17:04Z","board_verified":true,"closed_at":null,"days_open":96,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":96},"description":"Company Overview\nImmunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugates. Our pipeline includes varegacestat, an investigational gamma secretase inhibitor for which an NDA has been accepted by the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-1617, a clinical-stage solid tumor ADC; and IM-3050, a clinical-stage FAP-targeted radioligand therapy. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets.\nPosition Overview\nThe Director, Quality Operations will report to the Senior Director, Quality Assurance and provide strategic operational leadership and oversight across assigned programs related to clinical and commercial. This role will lead day-to-day activities around commercialization of Varegacestat and continuing Varegacestat clinical programs. Additional projects will eventually be added. They will work cross-functionally and with internal and external partners to ensure product quality throughout the development lifecycle and provide strategic quality leadership aligned with company objectives. Experience with small molecules and biologics is required. \nResponsibilities\nQuality Operations \nOversee quality aspects of starting material, intermediates, drug substance and drug product manufacturing as well as packaging/labeling activities. \nReview and approve specifications affecting product quality and oversee the development of master batch records, process and method validation/protocol reports and other technical documents created to support all stages of the product lifecycle, from development to commercialization. \nDisposition clinical and commercial batches. \nEnsure effective CAPA management, change controls, deviations, and other GMP-related processes are followed during manufacturing and testing of products. \nInteract with manufacturing, clinical, or other functional areas that impact quality operations and provide support as needed. \nPerform risk assessments and implement appropriate quality and process controls to ensure proper oversight of production activities. \nSupport vendor qualification program and monitor vendor performance. \nPrompt communication to management of potential compliance issues. \nParticipate in internal and external project team meetings. \nDocumentation and Record Control \nPerform periodic reviews and revisions of SOPs, policies, and Quality Agreements to align with regulatory updates and business needs. \nEstablish, review and/or approve Quality Agreements and ensure they are properly stored and managed. \nManage other internal and external documentation related to QA operations. \n Regulatory Compliance and Inspection Readiness \nEnsure external parties are inspection-ready, in compliance with regulatory requirements, and prepared for GMP audits or inspections from FDA or other international regulatory bodies. \nCollaborate with regulatory affairs and cross-functional teams to support regulatory submissions, including providing necessary documentation and ensuring compliance with filing requirements. \nSupport site preparation for regulatory inspections including personnel preparation and training. \nParticipate in Quality Management Review meetings, as needed. \nAssist in updating CMC sections of regulatory and quality documents. \n Operational Leadership and Continuous Improvement \nDrive continuous improvement initiatives across quality operations to enhance operational efficiency, reduce risk, and improve product quality. \nProvide strategic direction and hands-on leadership for operations teams, ensuring alignment with business goals and regulatory demands. \nDevelop and implement metrics to monitor and report on the performance of Operations, identifying areas for improvement and ensuring corrective actions are implemented. \nPromote a strong Quality culture within the organization. Identify compliance risks and be a part of the solution through ownership and collaboration. \nQualifications\nA minimum of 10 years of experience in Quality Assurance and GMP compliance within a pharmaceutical or biotechnology environment, or equivalent. \nExtensive experience supporting outsourced manufacturing models, including oversight of CMOs and external service providers. \nExperience working with small molecules and biologics (ideally ADCs). \nDemonstrated senior-level experience leading global regulatory inspections and managing inspection outcomes. \nSignificant experience supporting development-stage programs through commercial operations. \nProven experience with internal and external audits, CAPA management, and continuous improvement initiatives. \nAbility to travel up to 20% to support audits and regulatory inspections, domestic and international. \nKnowledge and Skills\nDeep technical knowledge of global GMP and GDP regulations, regulatory inspection expectations, and quality system requirements across development-stage and commercial operations. \nDemonstrated expertise in inspection readiness, regulatory inspections, and inspection response management, including FDA Form 483 responses, commitments, and remediation strategies. \nStrong understanding of quality systems, audit programs, CAPA management, recalls and risk-based compliance approaches in outsourced manufacturing environments. \nProven ability to lead quality governance, management/quality review processes, and regulatory surveillance activities. \nAbility to assess, prioritize, and mitigate quality and compliance risks across CMOs, vendors, and internal operations. \nStrong leadership presence with the ability to effectively influence executive leadership and cross-functional stakeholders. \nExcellent verbal, written, interpersonal, and communication skills, with the ability to clearly convey complex quality and compliance topics. \nWashington State Pay Range\n$212,149—$239,998 USD\nE/E/O\nImmunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.\nE-Verify\nImmunome, Inc. is a participant in E-Verify. Please review the following notices: E-Verify Participation Poster | Right to Work Poster (English) | Right to Work Poster (Spanish).","description_format":"text","description_chars":6449,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Oncology Therapeutics"],"lifecycle":[{"event":"open","at":"2026-09-11T18:59:32Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 3","filings_12m":3,"filings_prev_12m":1,"green_card_filings_12m":0,"median_offered_wage_usd":277500,"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)"],"filings_for_role_12m":0}],"liveness":{"score":16,"band":"cold","label":"Long shot","p_open":1,"p_active":0.572,"p_room":0.28,"age_days":96,"expected_fill_days":38,"reasons":["conf:4","win:tail","crowd:"],"computed_at":"2026-10-28T05:59:10Z"},"pay":{"stated_usd_annual":239998,"is_top_pay":false},"html_url":"https://alion.io/job/immunome-director-quality-operations","json_url":"https://alion.io/job/immunome-director-quality-operations.json","meta":{"generated_at":"2026-10-28T14:10:48Z","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":19331,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-29T00:00:00Z"}},"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":3828286},"rest":"https://alion.io/mcp/rest/get_company?id=3828286"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fimmunome-director-quality-operations"},{"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%2Fimmunome-director-quality-operations"},{"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%2Fimmunome-director-quality-operations"},{"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/immunome-director-quality-operations\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fimmunome-director-quality-operations"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":762769}},{"tool":"search_jobs","arguments":{"company":"immunome.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":762769},"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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