---
title: 'Senior Director, Development Quality Assurance at Immunome, Inc.'
canonical: 'https://feeny.ai/job/senior-director-development-quality-assurance-immunome-inc-bothell-jhn4eb9nzy7g'
type: 'job'
last_seen: '2026-10-17'
---

# Senior Director, Development Quality Assurance at Immunome, Inc.

- **Company:** Immunome, Inc.
- **Location:** Bothell, WA
- **Compensation:** $260k–$294k
- **Posted:** 2026-09-23
- **Last confirmed live:** 2026-10-17
- **Apply:** https://job-boards.greenhouse.io/immunomeinc/jobs/5432427008

## Job description

Company Overview

Immunome 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.

Position Overview

The 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.).

Reporting 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.

The 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.

## Responsibilities

Leadership & Quality Strategy

- Execute Development QA objectives and priorities established by the VP, Head of Development Quality Assurance.
- Partner with Development functional leaders to promote a culture of quality, compliance, accountability, patient safety, and continuous improvement.
- Serve as a trusted advisor and quality business partner across Clinical Development, Clinical Operations, Regulatory Affairs, Pharmacovigilance, Biometrics, and related functions.
- Provide quality guidance and recommendations to leadership regarding quality risks, compliance issues, inspection readiness, and process improvements.
- Develop and maintain quality metrics, risk indicators, and dashboards to support data-driven decision making and management oversight.
- Champion 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, identify risks earlier, enhance inspection readiness, and increase organizational efficiency.

Audit Planning & Execution

- Support and manage a risk-based audit program for clinical programs, vendors, and associated development activities.
- Collaborate with Clinical Operations, Regulatory Affairs, Pharmacovigilance, and other stakeholders to identify areas of quality risk and establish audit priorities.
- Lead or oversee internal and external audits of clinical sites, CROs, laboratories, vendors, and quality systems, as appropriate.
- Utilize audit outcomes as one component of a broader quality oversight framework to identify opportunities for process improvement and risk mitigation.
- Review audit findings, support root cause analyses, and ensure effective CAPAs are developed, implemented, and monitored for effectiveness.
- Analyze audit trends and communicate emerging compliance risks and recommendations to senior management.

Regulatory Inspection Management

- Lead and coordinate operational inspection readiness activities across Development functions.
- Partner with stakeholders to ensure continuous readiness for regulatory inspections conducted by FDA, EMA, MHRA, PMDA, and other Health Authorities.
- Conduct inspection readiness assessments, mock inspections, document reviews, and interview coaching activities.
- Support hosting and management of regulatory inspections and serve as a key quality representative during inspection activities.
- Ensure timely and effective responses to regulatory observations, inspection findings, and commitments.
- Work with functional teams to embed inspection readiness into routine operations rather than periodic preparation efforts.

Procedural Documentation & Compliance

- Lead the development, review, revision, approval, and implementation of Development SOPs, standards, templates, and guidance documents.
- Partner directly with process owners and subject matter experts to create practical, compliant, and scalable procedures.
- Ensure procedural documentation remains aligned with evolving regulatory requirements, industry best practices, and business needs.
- Develop and deliver training and educational programs to enhance organizational understanding of quality requirements, risk management, inspection readiness, and compliance expectations.
- Establish and communicate clear guidance regarding the role of Development QA and when functional teams should engage QA support.
- Create tools, onboarding materials, communications, and training resources that help functional teams understand Development QA services, responsibilities, and value.
- Support quality event management activities, including deviations, investigations, CAPAs, and documentation within the Quality Management System.

Vendor & CRO Management

- Support qualification, oversight, and ongoing evaluation of CROs, laboratories, pharmacovigilance providers, technology vendors, and other external partners.
- Participate in vendor risk assessments and support the establishment of appropriate oversight models.
- Review vendor performance trends, quality metrics, and compliance risks and provide recommendations for improvement actions.
- Ensure quality expectations, responsibilities, and oversight requirements are appropriately communicated and maintained throughout the vendor lifecycle.
- Act as a quality resource during vendor selection, governance, issue management, and escalation activities.

Continuous Improvement

- Partner with GMP Quality Assurance leadership to establish, implement, and continuously improve a unified enterprise Quality Management System supporting GMP, GCP, GLP, and GVP activities.
- Drive harmonization and simplification of quality processes across Development and Manufacturing organizations while meeting applicable regulatory requirements.
- Facilitate quality risk assessments and support Development teams in proactively identifying, escalating, and mitigating compliance risks.
- Develop and maintain risk registers, quality dashboards, and metrics that provide visibility into organizational quality performance and emerging risks.
- Support Serious Breach assessments, significant protocol deviations, quality event investigations, and related compliance activities.
- Identify and implement continuous improvement initiatives that enhance operational efficiency, compliance effectiveness, and inspection readiness.
- Evaluate, implement, and leverage emerging technologies, including Artificial Intelligence (AI) and Machine Learning (ML), to improve the efficiency, effectiveness, and scalability of Development Quality processes.
- Partner with Quality, Clinical Development, and Technology teams to identify opportunities for AI-enabled automation of quality workflows, document management, SOP lifecycle activities, training management, quality reporting, and risk monitoring.
- Ensure AI-enabled solutions are appropriately governed, risk-assessed, and implemented in accordance with company procedures and applicable regulatory expectations.
- Apply data analytics and predictive quality approaches to identify trends, detect emerging risks, and support proactive quality oversight.

## Qualifications

- Bachelor's or Master's degree in Chemistry, Biochemistry, Clinical Pharmacology, Life Sciences, or related field.
- Minimum of 15 years of experience in biotechnology, pharmaceutical, or life sciences, quality assurance, clinical development, or related GxP-regulated environments.
- Minimum of 5 years of leadership experience managing quality professionals and supporting quality systems, inspection readiness, compliance programs, and quality oversight activities.
- Demonstrated experience building, implementing, or improving Quality Management Systems and quality processes.
- Significant experience supporting global clinical development programs and regulatory inspections.
- Experience with biologics, antibody-drug conjugates (ADCs), radiopharmaceuticals, and/or small molecule development preferred.

Knowledge and Skills

- Deep knowledge of GCP, GLP, GVP, FDA, EMA, ICH guidelines, and global regulatory requirements applicable to clinical development.
- Strong understanding of risk-based quality management principles, inspection readiness, and Quality Management System processes.
- Experience developing, reviewing, and implementing SOPs, standards, guidance documents, and quality system processes.
- Demonstrated success partnering with Clinical Operations, Clinical Development, Pharmacovigilance, Regulatory Affairs, and external partners to improve quality and compliance outcomes.
- Experience supporting Health Authority inspections, Serious Breach assessments, quality event investigations, CAPA management, and risk management activities.
- Strong communication skills with the ability to influence, coach, train, and collaborate effectively across a global, cross-functional organization.
- Excellent analytical, organizational, and problem-solving abilities with a demonstrated capability to assess risk and provide practical recommendations.
- Strong project management, change management, and organizational effectiveness skills.
- Experience developing quality metrics, dashboards, and management reporting tools.
- Proficiency with electronic Quality Management Systems and quality documentation platforms such as TrackWise, MasterControl, Veeva Quality, or equivalent systems.
- Demonstrated ability to leverage technology, automation, AI, and advanced analytics to improve quality processes and operational efficiency.

Washington State Pay Range $260,000—$293,977 USD

E/E/O

Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

E-Verify

Immunome, Inc. is a participant in E-Verify. Please review the following notices: [E-Verify Participation Poster](https://immunome.box.com/s/bopxukipfidxjscs4bjxt75f90bvpppk) | https://immunome.box.com/s/r51g9subw1wqni9xkutbl6up635sjr8e | https://immunome.box.com/s/r3ekbimwh988my9vzl76tnlbg60zvh9u.

## About Immunome, Inc.

## Company Overview
- **One-liner**: Immunome is a clinical-stage oncology company developing first-in-class and best-in-class targeted cancer therapies, with a primary focus on antibody-drug conjugates (ADCs).
- **Entity Type**: Public (Nasdaq: IMNM)
- **Headquarters**: Bothell, Washington, United States
- **Founded**: The company was formed through a merger of Morphimmune and Immunome in October 2023.
- **Founders**: The company is led by Clay Siegall, Ph.D. (Chairman, CEO, and President), who co-founded Seagen. The original Immunome entity was founded earlier, but the current company structure dates to the 2023 merger.

## Core Business
- Primary industry/industries: Biotechnology, Oncology, Drug Discovery & Development
- Target customers: Patients with cancer, healthcare providers, and clinical trial sites. The company is a B2B/B2C entity in the healthcare and life sciences space.
- Mission or purpose statement: "Our mission is to improve outcomes for cancer patients by advancing and expanding a portfolio of first-in-class and best-in-class therapeutic candidates." [immunome.com](https://immunome.com/)

## Products & Services
- **Varegacestat (formerly AL102)**: A late-clinical stage gamma secretase inhibitor for the treatment of desmoid tumors. The company submitted a New Drug Application (NDA) to the U.S. FDA in April 2026. [investors.immunome.com](https://investors.immunome.com/)
- **IM-1021**: A ROR1-targeted antibody-drug conjugate (ADC) currently in a Phase 1 trial.
- **IM-3050**: A FAP-targeted radioligand which received IND clearance in Q1 2025.
- **Preclinical ADC Pipeline (IM-1617, IM-1340, IM-1335)**: ADCs pursuing undisclosed targets with expression in multiple solid tumors. IM-1617 had its first patient dosed in a Phase 1 trial in June 2026. [investors.immunome.com](https://investors.immunome.com/)

## Market Standing
- **Valuation/Market Cap**: Not publicly available in the search results. As a public company, this fluctuates. (Check recent filings for current data).
- **Key Metric**: The company is pre-revenue (clinical-stage) and has raised significant capital. Since the 2023 merger, CEO Clay Siegall has raised $355 million in equity financings. [immunome.com](https://immunome.com/about/)
- **Notable Investors/Partners**: The company is publicly traded. Key leadership previously worked at Seagen (acquired by Pfizer for $43 billion).
- **Growth Signals**: The company is rapidly advancing its pipeline. Key milestones include the NDA submission for varegacestat, first patient dosed for IM-1617, and positive Phase 3 data presented at ASCO 2026. The company currently lists 32 open positions on its careers page, indicating strong hiring momentum. [job-boards.greenhouse.io](http://job-boards.greenhouse.io/immunomeinc)

## Competitive Advantages
- **World-Class Leadership**: The executive team, led by Seagen co-founder Clay Siegall, has deep experience in designing, developing, and commercializing blockbuster ADCs (ADCETRIS, PADCEV, TIVDAK, TUKYSA). [immunome.com](https://immunome.com/about/)
- **Proprietary ADC Platform**: A systematic, data-driven process for optimizing antibodies, linkers, and payloads to create differentiated ADCs. [immunome.com](https://immunome.com/)
- **Near-Term Catalyst**: The NDA submission for varegacestat provides a potential near-term commercial opportunity.
- **Strong Financial Backing**: Raised $355M in equity since the merger, providing a solid runway for pipeline advancement.

## Strategic Focus
- **Advancing the Pipeline**: The primary focus is on executing clinical trials for varegacestat (Phase 3), IM-1021 (Phase 1), and IM-3050 (Phase 1), and advancing preclinical ADCs into the clinic.
- **Regulatory Filing**: Successfully navigating the FDA NDA submission and potential approval for varegacestat.
- **Discovery & Expansion**: Using their ADC discovery platform to generate new candidates and identify and acquire targeted oncology assets to expand the portfolio. [immunome.com](https://immunome.com/about/)

## Why Work Here
- **Mission-Driven**: The work directly impacts the lives of cancer patients, with a stated goal of developing transformative therapies. [immunome.com](https://immunome.com/about/)
- **High-Impact Team**: Opportunity to work with "some of the brightest and most experienced minds in ADC development," including leaders who have brought multiple drugs to market. [immunome.com](https://immunome.com/careers/)
- **Growth Stage**: With 32 open roles, the company is in a rapid growth phase, offering significant career advancement opportunities. [job-boards.greenhouse.io](http://job-boards.greenhouse.io/immunomeinc)
- **Comprehensive Benefits**: Includes 100% company-paid medical premiums for employees, a 401(k) with employer match, paid parental leave, and a week-long winter break. [immunome.com](https://immunome.com/careers/)
- **Location & Culture**: Based in Bothell, WA. The company describes a culture of "innovative, collaborative environment where employees are empowered to do their best work." [immunome.com](https://immunome.com/careers/)

## Sources
1. [Immunome Official Website](https://immunome.com/)
2. [Immunome About Page](https://immunome.com/about/)
3. [Immunome Investor Relations](https://investors.immunome.com/)
4. [Immunome Careers Page](https://immunome.com/careers/)
5. [Immunome Jobs on Greenhouse](http://job-boards.greenhouse.io/immunomeinc)

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