Senior Director, Data Integrity Quality Assurance

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.