Senior Director, Data Integrity Quality Assurance

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.

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.

• 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.

• 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.

• 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.

• 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…