---
title: 'Director, Quality Operations at Immunome, Inc.'
canonical: 'https://feeny.ai/job/director-quality-operations-immunome-inc-bothell-washington-jj9mjqrnq29x'
type: 'job'
last_seen: '2026-09-19'
---

# Director, Quality Operations at Immunome, Inc.

- **Company:** Immunome, Inc.
- **Location:** Bothell Washington, United States
- **Compensation:** $212k–$240k
- **Posted:** 2026-07-23
- **Last confirmed live:** 2026-09-19
- **Apply:** https://job-boards.greenhouse.io/immunomeinc/jobs/5369013008

## 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 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.

## Responsibilities

Quality Operations

- Oversee quality aspects of starting material, intermediates, drug substance and drug product manufacturing as well as packaging/labeling activities.
- Review 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.
- Disposition clinical and commercial batches.
- Ensure effective CAPA management, change controls, deviations, and other GMP-related processes are followed during manufacturing and testing of products.
- Interact with manufacturing, clinical, or other functional areas that impact quality operations and provide support as needed.
- Perform risk assessments and implement appropriate quality and process controls to ensure proper oversight of production activities.
- Support vendor qualification program and monitor vendor performance.
- Prompt communication to management of potential compliance issues.
- Participate in internal and external project team meetings.

Documentation and Record Control

- Perform periodic reviews and revisions of SOPs, policies, and Quality Agreements to align with regulatory updates and business needs.
- Establish, review and/or approve Quality Agreements and ensure they are properly stored and managed.
- Manage other internal and external documentation related to QA operations.

Regulatory Compliance and Inspection Readiness

- Ensure external parties are inspection-ready, in compliance with regulatory requirements, and prepared for GMP audits or inspections from FDA or other international regulatory bodies.
- Collaborate with regulatory affairs and cross-functional teams to support regulatory submissions, including providing necessary documentation and ensuring compliance with filing requirements.
- Support site preparation for regulatory inspections including personnel preparation and training.
- Participate in Quality Management Review meetings, as needed.
- Assist in updating CMC sections of regulatory and quality documents.

Operational Leadership and Continuous Improvement

- Drive continuous improvement initiatives across quality operations to enhance operational efficiency, reduce risk, and improve product quality.
- Provide strategic direction and hands-on leadership for operations teams, ensuring alignment with business goals and regulatory demands.
- Develop and implement metrics to monitor and report on the performance of Operations, identifying areas for improvement and ensuring corrective actions are implemented.
- Promote a strong Quality culture within the organization.  Identify compliance risks and be a part of the solution through ownership and collaboration.

## Qualifications

- A minimum of 10 years of experience in Quality Assurance and GMP compliance within a pharmaceutical or biotechnology environment, or equivalent.
- Extensive experience supporting outsourced manufacturing models, including oversight of CMOs and external service providers.
- Experience working with small molecules and biologics (ideally ADCs).
- Demonstrated senior-level experience leading global regulatory inspections and managing inspection outcomes.
- Significant experience supporting development-stage programs through commercial operations.
- Proven experience with internal and external audits, CAPA management, and continuous improvement initiatives.
- Ability to travel up to 20% to support audits and regulatory inspections, domestic and international.

Knowledge and Skills

- Deep technical knowledge of global GMP and GDP regulations, regulatory inspection expectations, and quality system requirements across development-stage and commercial operations.
- Demonstrated expertise in inspection readiness, regulatory inspections, and inspection response management, including FDA Form 483 responses, commitments, and remediation strategies.
- Strong understanding of quality systems, audit programs, CAPA management, recalls and risk-based compliance approaches in outsourced manufacturing environments.
- Proven ability to lead quality governance, management/quality review processes, and regulatory surveillance activities.
- Ability to assess, prioritize, and mitigate quality and compliance risks across CMOs, vendors, and internal operations.
- Strong leadership presence with the ability to effectively influence executive leadership and cross-functional stakeholders.
- Excellent verbal, written, interpersonal, and communication skills, with the ability to clearly convey complex quality and compliance topics.

Washington State Pay Range $212,149—$239,998 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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