Development Quality Assurance Director

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 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

Leadership & Quality Strategy  

• Execute Development QA objectives and priorities established by the VP, Head of Development Quality Assurance.  

• Partner with Development functional leaders to promote a culture of quality, compliance, accountability, patient safety, and continuous improvement.  

• Serve as a trusted advisor and quality business partner across Clinical Development, Clinical Operations, Regulatory Affairs, Pharmacovigilance, Biometrics, and related functions.