---
title: 'Senior Director, Data Integrity Quality Assurance at Immunome, Inc.'
canonical: 'https://feeny.ai/job/senior-director-data-integrity-quality-assurance-immunome-inc-bothell-washington-0nwybaranp8g'
type: 'job'
last_seen: '2026-09-12'
---

# Senior Director, Data Integrity Quality Assurance at Immunome, Inc.

- **Company:** Immunome, Inc.
- **Location:** Bothell Washington, United States
- **Compensation:** $260k–$294k
- **Posted:** 2026-09-09
- **Last confirmed live:** 2026-09-12
- **Apply:** https://job-boards.greenhouse.io/immunomeinc/jobs/5419743008

## 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

Reporting to the Senior Vice President, Quality, the Senior Director, Data Integrity Quality Assurance will establish, lead, and continuously improve Immunome’s global data integrity (DI) strategy and governance program across all GxP-regulated operations (GMP, GLP, GCP, and GVP).

This role partners closely with Quality, IT/Digital, Technical Operations, Clinical Development, Regulatory Affairs, and other business functions to identify data integrity risks, design and implement sustainable controls, drive inspection readiness, and foster a culture of data ownership and accountability across the organization. The role carries enterprise-wide accountability for data integrity and computerized system validation (CSV) governance and serves as the company’s subject-matter expert during health authority inspections.

## Responsibilities

Data Integrity Strategy & Governance

- Establish and own a risk-based, enterprise-wide data integrity strategy, governance framework, and supporting policies/procedures aligned with applicable GxP requirements and industry expectations, including ALCOA++ principles.
- Provide Quality Assurance oversight of computerized systems, including validation, risk assessments, Quality System records, and GxP IT vendor management.
- Lead regulatory inspection readiness for data integrity and computerized system validation (CSV) and serve as the subject-matter expert and company representative during inspections.

Computerized Systems and Digital Quality

- Partner with IT/Digital and business functions to ensure GxP computerized systems are appropriately governed throughout their lifecycle.
- Ensure systems and processes comply with electronic records and electronic signature requirements, including 21 CFR Part 11, EU GMP Annex 11, and applicable data protection regulations.
- Provide Quality input into computerized system selection, configuration, implementation, validation, migration, integration, change control/CAPA, periodic review, decommissioning, and archival.
- Ensure data migration, conversion, transfer, and integration activities preserve data accuracy, completeness, traceability, and context, along with compliant, reviewable audit trails.
- Evaluate and oversee data integrity controls at CDMOs, CROs, laboratories, and other GxP suppliers and vendors, including risk-based audits and remediation follow-up.
- Ensure procedures adequately address original records, true copies, metadata, dynamic records, raw data, and paper/hybrid records across the data lifecycle.

Training and Quality Culture

- Provide Quality leadership for data integrity and CSV, and act as an escalation point for DI-related risks and events across the organization.
- Develop and deliver an enterprise-wide data integrity training curriculum (role-based, GxP-tiered) and promote a strong culture of quality and data integrity.
- Ensure data integrity requirements are built into GxP processes, computerized systems, instruments, equipment, and data repositories by design.
- Partner with functional leaders to embed data integrity controls into daily operations in a practical, risk-proportionate way that avoids unnecessary complexity or administrative burden.
- Lead or participate in internal QA audits, self-inspections, and assessments focused on data integrity and CSV.

Leadership and People Management

- Build, lead, and develop a high-performing Data Integrity Quality team, setting clear objectives, priorities, and performance expectations.
- Mentor, coach, and develop team members, fostering technical expertise, career growth, and leadership readiness.
- Manage consultants and external subject-matter experts to supplement the team when specialized data integrity or CSV support is required.
- Advise senior leadership on data governance, including data integrity risk posture, regulatory trends, remediation priorities, and resourcing needs; represent Quality on relevant governance and risk committees.

## Qualifications

- Bachelor's degree in Life Sciences, Engineering, Computer Science, Information Systems, Quality, or a related discipline; advanced degree preferred.
- A minimum of 12+ years of progressive GxP Quality, Data Integrity, Compliance, and Computerized Systems Validation experience within a pharmaceutical or biotechnology environment, or equivalent, including 5+ years of direct people leadership.
- Demonstrated experience leading data integrity and/or CSV programs through health authority inspections (FDA, EMA, MHRA, or other global regulators), including inspection response and remediation.
- Certified Quality Auditor (ASQ CQA), CISA, or equivalent data integrity/CSV certification preferred, but not required.
- Ability to travel up to 15–20% domestically and internationally to support audits, inspections, and vendor assessments.

Knowledge and Skills

- Deep technical knowledge of Computerized System Validation (CSV) approaches.
- Strong command of Electronic Records and Electronic Signature (ERES) requirements, including 21 CFR Part 11 and EU GMP Annex 11.
- Proven strategic leadership skills, with the ability to build and scale a data integrity program in a growing clinical-stage or commercial biotech organization.
- Broad regulatory expertise across GxP domains and current global data integrity guidance (FDA, MHRA, EMA, PIC/S, WHO).
- Working knowledge of Quality Management Systems (QMS), including deviations, CAPA, change control, and audit management.
- Excellent executive communication and influencing skills, with the ability to convey complex data integrity and compliance topics to senior leadership and external inspectors.
- Track record of driving continuous improvement and operational efficiency without compromising compliance or quality.

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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