---
title: 'Associate Director / Director, Supplier Quality and Audits at Immunome, Inc.'
canonical: 'https://feeny.ai/job/associate-director-director-supplier-quality-and-audits-immunome-inc-bothell-ghr7p8132g36'
type: 'job'
last_seen: '2026-09-19'
---

# Associate Director / Director, Supplier Quality and Audits at Immunome, Inc.

- **Company:** Immunome, Inc.
- **Location:** Bothell Washington, United States
- **Compensation:** $175k–$240k
- **Posted:** 2026-07-08
- **Last confirmed live:** 2026-09-19
- **Apply:** https://job-boards.greenhouse.io/immunomeinc/jobs/5303860008

## 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 / Associate Director, Supplier Quality and Audits supports the Head of GMP Quality Compliance in building and continuously improving Immunome’s Supplier Quality Compliance and Audit Program.

This role leads supplier audit management, vendor governance, compliance monitoring, risk management, quality agreements, CAPA management, and inspection readiness for GxP suppliers and service providers, including CDMOs, CROs, contract laboratories, consultants, and other outsourced partners. It ensures supplier compliance and audit processes are risk-based, inspection-ready, and aligned with regulatory requirements and Immunome’s Quality Management System, while maintaining an effective audit program and governance of outsourced GxP activities.

As a virtual biotechnology company, Immunome retains ultimate responsibility for the quality and compliance of outsourced operations, and this role is a key partner in ensuring audit effectiveness, governance, and inspection readiness across the product lifecycle. This role partners closely with Quality Operations, which manages day-to-day supplier oversight, while this position provides independent compliance oversight through risk assessments, audits, governance, and remediation follow-up.

## Responsibilities

- Support development and continuous improvement of Immunome’s GxP Supplier Quality and Vendor Management Program.
- Lead supplier qualification, risk classification, onboarding, and ongoing monitoring of GxP vendors and service providers.
- Maintain supplier quality records, risk evaluations, audit reports, and performance metrics.
- Support quality oversight of CDMOs, CROs, labs, consultants, and other outsourced service providers.
- Partner with stakeholders to clearly define and maintain vendor responsibilities and compliance expectations.
- Lead negotiation and lifecycle management of quality agreements.
- Plan and conduct supplier audits and follow-up, including responses, CAPAs, and effectiveness checks.
- Support inspection readiness for outsourced GxP operations, including regulatory and internal audit preparation.
- Monitor supplier quality performance, including deviations, CAPAs, complaints, audit findings, and service-level trends.
- Identify, escalate, and support remediation of supplier quality and compliance risks.
- Support cross-functional vendor governance meetings and document decisions, actions, and follow-up commitments.
- Develop and maintain supplier quality procedures, Quality Agreement templates, and related trackers and tools aligned with Immunome’s Quality Management System and regulatory expectations.
- Support continuous improvement of supplier quality, oversight, audit effectiveness, and inspection readiness.

## Qualifications

- Bachelor’s degree in a scientific, technical, or related field; advanced degree preferred.
- 8+ years of biopharmaceutical industry experience, including direct oversight of third parties performing GxP activities, cGMP manufacturing, testing, or clinical operations, or equivalent experience.
- Demonstrated experience performing and managing supplier qualification and supplier audit programs.
- Experience supporting virtual, outsourced, or external manufacturing and service provider models preferred.
- Ability to travel domestically and internationally up to 20%, with occasional evening/weekend commitment to support audits and inspections.
- Professional certifications (e.g., ASQ CQA, CMQ/OE, RQAP, ISO 9001/13485 Lead Auditor, RAC) or equivalent quality/auditing/regulatory certifications are highly desirable.

Knowledge and Skills

- Strong knowledge of Supplier Quality Management, GxP auditing, Quality Systems, and regulatory compliance within the biotechnology or pharmaceutical industry.
- Experience managing supplier qualification, governance, quality agreements, risk assessments, and oversight of CDMOs, CROs, labs, and other GxP service providers.
- Demonstrated experience conducting supplier audits, managing audit programs, supporting regulatory inspections, CAPA management, and inspection readiness activities.
- Proven Lead Auditor experience with strong knowledge of FDA, EU, ICH, and applicable GxP regulations.
- Strong understanding of cGMP manufacturing, quality assurance/control, validation, and outsourced pharmaceutical operations.
- Experience developing audit schedules, audit plans, audit reports, and auditor training programs.
- Excellent organizational, communication, collaboration, negotiation, analytical, and problem-solving skills.
- Ability to manage multiple priorities in a fast-paced environment and adapt effectively to changing business needs.

Washington State Pay Range $175,100—$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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