Senior Director, Development Quality Assurance

Position Overview

The Senior Director, Development Quality Assurance (DQA) is responsible for implementing and executing quality assurance strategies that support Immunome's clinical development activities and ensure compliance with applicable Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practice (GVP), and global regulatory requirements (FDA, EMA, ICH, etc.).  

Reporting to the Vice President, Head of Development Quality Assurance, this role serves as a key quality partner to Clinical Development, Clinical Operations, Pharmacovigilance, Regulatory Affairs, Biometrics, Medical Writing, and other Development functions. The Senior Director collaborates closely with functional teams to identify and mitigate risk, develop compliant and efficient processes, strengthen inspection readiness, and build organizational quality capabilities.  

The Senior Director will help establish and maintain a fit-for-purpose Quality Management System (QMS), drive quality culture throughout the organization, and provide expertise, guidance, training, and partnership to support successful execution of Immunome's development programs. The role emphasizes proactive quality oversight, continuous improvement, risk-based decision-making, and inspection readiness while utilizing audits as one component of a broader quality assurance framework.  

Responsibilities

Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Immunome, Inc. is a participant in E-Verify. Please review the following notices: E-Verify Participation Poster | Right to Work Poster (English) | Right to Work Poster (Spanish).