{"id":1158712,"url":"https://alion.io/job/immunome-senior-director-development-quality-assurance","title":"Senior Director, Development Quality Assurance","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":94,"open_postings":4,"ghost_share":0,"stale_share":0.25,"repost_share":0,"time_to_fill_p50_days":47,"computed_at":"2026-11-01T06:10:25Z"}},"role":"Leadership","role_family":"Leadership","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":260000,"max":293977,"currency":"USD","period":"year","gross":null,"usd_annual":293977},"salary_estimate":null,"experience_years_min":15,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GCP","optional":false},{"name":"GLP","optional":false},{"name":"GMP","optional":false},{"name":"Good Clinical Practice","optional":false},{"name":"Machine Learning","optional":false},{"name":"Veeva","optional":false}],"status":"live","first_seen_at":"2026-09-23T19:08:39Z","employer_posted_date":"2026-09-23","last_verified_at":"2026-11-01T09:21:59Z","board_verified":true,"closed_at":null,"days_open":38,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":38},"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 Senior Director, Development Quality Assurance (DQA) is responsible for implementing and executing quality assurance strategies that support Immunome's clinical development activities and ensure compliance with applicable Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practice (GVP), and global regulatory requirements (FDA, EMA, ICH, etc.). \nReporting to the Vice President, Head of Development Quality Assurance, this role serves as a key quality partner to Clinical Development, Clinical Operations, Pharmacovigilance, Regulatory Affairs, Biometrics, Medical Writing, and other Development functions. The Senior Director collaborates closely with functional teams to identify and mitigate risk, develop compliant and efficient processes, strengthen inspection readiness, and build organizational quality capabilities. \nThe Senior Director will help establish and maintain a fit-for-purpose Quality Management System (QMS), drive quality culture throughout the organization, and provide expertise, guidance, training, and partnership to support successful execution of Immunome's development programs. The role emphasizes proactive quality oversight, continuous improvement, risk-based decision-making, and inspection readiness while utilizing audits as one component of a broader quality assurance framework. \nResponsibilities\nLeadership & Quality Strategy \nExecute Development QA objectivesand priorities establishedby the VP, Head of Development Quality Assurance. \nPartner with Development functional leaders to promote a culture of quality, compliance, accountability, patient safety, and continuous improvement. \nServe as a trusted advisor and quality business partner across Clinical Development, Clinical Operations, Regulatory Affairs, Pharmacovigilance, Biometrics, and related functions. \nProvide quality guidance and recommendations to leadership regardingquality risks, compliance issues, inspectionreadiness, and process improvements. \nDevelop and maintainquality metrics, risk indicators, and dashboards to support data-driven decision making and management oversight. \nChampion innovative approaches, including Artificial Intelligence (AI) and advanced analytics, to enable a modern Development QA organization that uses data-driven insights to improve decision-making, identifyrisks earlier, enhance inspection readiness, and increase organizational efficiency. \n\nAudit Planning & Execution \nSupport and manage a risk-based audit program for clinical programs, vendors, and associated development activities. \nCollaborate with Clinical Operations, Regulatory Affairs, Pharmacovigilance, and other stakeholders to identifyareas of quality risk and establishaudit priorities. \nLead or oversee internal and external audits of clinical sites, CROs, laboratories, vendors, and quality systems, as appropriate. \nUtilize audit outcomes as one componentof a broader quality oversight framework to identifyopportunities for process improvement and risk mitigation. \nReview audit findings, support root cause analyses, and ensure effective CAPAs are developed, implemented, and monitoredfor effectiveness. \nAnalyze audit trends and communicate emerging compliance risks and recommendations to senior management. \n\nRegulatory Inspection Management \nLead and coordinate operational inspectionreadiness activities across Development functions. \nPartner with stakeholders to ensure continuous readiness for regulatory inspections conducted by FDA, EMA, MHRA, PMDA, and other Health Authorities. \nConduct inspectionreadiness assessments, mock inspections, document reviews, and interview coaching activities. \nSupport hosting and management of regulatory inspections and serve as a key quality representative during inspection activities. \nEnsure timelyand effective responses to regulatory observations, inspectionfindings, and commitments. \nWork with functional teams to embed inspection readiness into routine operations rather than periodic preparation efforts. \n\nProcedural Documentation & Compliance \nLead the development, review, revision, approval, and implementation of Development SOPs, standards, templates, and guidance documents. \nPartner directly with process owners and subject matter experts to create practical, compliant, and scalable procedures. \nEnsure procedural documentation remainsaligned with evolving regulatory requirements, industry best practices, and business needs. \nDevelop and deliver training and educational programs to enhance organizational understanding of quality requirements, risk management, inspectionreadiness, and compliance expectations. \nEstablish and communicate clear guidance regardingthe role of Development QA and when functional teams should engage QA support. \nCreate tools, onboarding materials, communications, and training resources that help functional teams understand Development QA services, responsibilities, and value. \nSupport quality event management activities, including deviations, investigations, CAPAs, and documentation within the Quality Management System. \n\nVendor & CRO Management \nSupport qualification, oversight, and ongoing evaluation of CROs, laboratories, pharmacovigilance providers, technology vendors, and other external partners. \nParticipate in vendor risk assessments and support the establishment of appropriate oversightmodels. \nReview vendor performance trends, quality metrics, and compliance risks and provide recommendations for improvement actions. \nEnsure quality expectations, responsibilities, and oversight requirements are appropriately communicated and maintainedthroughout the vendorlifecycle. \nAct as a quality resource during vendor selection, governance, issue management, and escalation activities. \n\nContinuous Improvement \nPartner with GMP Quality Assurance leadership to establish, implement, and continuously improve a unified enterprise Quality Management System supporting GMP, GCP, GLP, and GVP activities. \nDrive harmonization and simplification of quality processes across Development and Manufacturing organizations while meeting applicable regulatory requirements. \nFacilitate quality risk assessments and support Development teams in proactively identifying, escalating, and mitigating compliance risks. \nDevelop and maintainrisk registers, quality dashboards, and metrics that provide visibility into organizational quality performance and emerging risks. \nSupport Serious Breach assessments, significant protocol deviations, quality event investigations, and related compliance activities. \nIdentifyand implement continuous improvement initiatives that enhance operational efficiency, compliance effectiveness, and inspectionreadiness. \nEvaluate, implement, and leverageemerging technologies, including Artificial Intelligence (AI) and Machine Learning (ML), to improve the efficiency, effectiveness, and scalability of Development Quality processes. \nPartner with Quality, Clinical Development, and Technology teams to identifyopportunities for AI-enabled automation of quality workflows, document management, SOP lifecycle activities, training management, quality reporting, and risk monitoring. \nEnsure AI-enabled solutions are appropriately governed, risk-assessed, and implemented in accordance withcompany procedures and applicable regulatory expectations. \nApply data analytics and predictive quality approaches to identifytrends, detect emerging risks, and support proactive quality oversight. \n\nQualifications\nBachelor's or Master's degree in Chemistry, Biochemistry, Clinical Pharmacology, Life Sciences, or related field. \nMinimum of 15 years of experience in biotechnology, pharmaceutical, or life sciences, quality assurance, clinical development, or related GxP-regulated environments. \nMinimum of 5 years of leadership experience managing quality professionals and supporting quality systems, inspectionreadiness, compliance programs, and quality oversight activities. \nDemonstrated experiencebuilding, implementing, or improving Quality Management Systems and quality processes. \nSignificant experiencesupporting global clinical development programs and regulatory inspections. \nExperience with biologics, antibody-drug conjugates (ADCs), radiopharmaceuticals, and/or small molecule development preferred. \n\nKnowledge and Skills\nDeep knowledge of GCP, GLP, GVP, FDA, EMA, ICH guidelines, and global regulatory requirements applicable to clinical development. \nStrong understanding of risk-based quality management principles, inspectionreadiness, and Quality Management System processes. \nExperience developing, reviewing, and implementing SOPs, standards, guidance documents, and quality system processes. \nDemonstrated success partnering with Clinical Operations, Clinical Development, Pharmacovigilance, Regulatory Affairs, and external partners to improve quality and compliance outcomes. \nExperience supporting Health Authority inspections, Serious Breach assessments, quality event investigations, CAPA management, and risk management activities. \nStrong communicationskills with the ability to influence, coach, train, and collaborate effectively across a global, cross-functional organization. \nExcellent analytical, organizational, and problem-solving abilities with a demonstrated capability to assess risk and provide practical recommendations. \nStrong project management, change management, and organizational effectiveness skills. \nExperience developing quality metrics, dashboards, and management reporting tools. \nProficiencywith electronic Quality Management Systems and quality documentation platforms such as TrackWise, MasterControl, Veeva Quality, or equivalent systems. \nDemonstrated ability to leveragetechnology, automation, AI, and advanced analytics to improve quality processes and operational efficiency. \n\nWashington State Pay Range\n$260,000—$293,977 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":10978,"description_truncated":false,"requirements":{"experience_years_min":15,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Oncology Therapeutics"],"lifecycle":[{"event":"open","at":"2026-09-26T04:27:40Z"},{"event":"open","at":"2026-10-22T07:55:40Z"}],"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":"2026-10-29T16:27:21+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)"],"filings_for_role_12m":0}],"liveness":{"score":62,"band":"ok","label":"Likely open","p_open":1,"p_active":0.832,"p_room":0.75,"age_days":38,"expected_fill_days":47,"reasons":["conf:1","win:late"],"computed_at":"2026-11-01T06:10:25Z"},"pay":{"stated_usd_annual":293977,"is_top_pay":true},"html_url":"https://alion.io/job/immunome-senior-director-development-quality-assurance","json_url":"https://alion.io/job/immunome-senior-director-development-quality-assurance.json","meta":{"generated_at":"2026-11-01T12:38:40Z","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":19463,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-02T00:00:00Z"}},"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-senior-director-development-quality-assurance"},{"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-senior-director-development-quality-assurance"},{"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-senior-director-development-quality-assurance"},{"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-senior-director-development-quality-assurance\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fimmunome-senior-director-development-quality-assurance"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":1158712}},{"tool":"search_jobs","arguments":{"company":"immunome.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":1158712},"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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