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

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.  

• Provide quality guidance and recommendations to leadership regarding quality risks, compliance issues, inspection readiness, and process improvements.  

• Develop and maintain quality metrics, risk indicators, and dashboards to support data-driven decision making and management oversight.  

• Champion innovative approaches, including Artificial Intelligence (AI) and advanced analytics, to enable a modern Development QA organization that uses data-driven insights to improve decision-making, identify risks earlier, enhance inspection readiness, and increase organizational efficiency.  

Audit Planning & Execution  

• Support and manage a risk-based audit program for clinical programs, vendors, and associated development activities.  

• Collaborate with Clinical Operations, Regulatory Affairs, Pharmacovigilance, and other stakeholders to identify areas of quality risk and establish audit priorities.  

• Lead or oversee internal and external audits of clinical sites, CROs, laboratories, vendors, and quality systems, as appropriate.  

• Utilize audit outcomes as one component of a broader quality oversight framework to identify opportunities for process improvement and risk mitigation.  

• Review audit findings, support root cause analyses, and ensure effective CAPAs are developed, implemented, and monitored for effectiveness.  

• Analyze audit trends and communicate emerging compliance risks and recommendations to senior management.  

Regulatory Inspection Management  

• Lead and coordinate operational inspection readiness activities across Development functions.  

• Partner with stakeholders to ensure continuous readiness for regulatory inspections conducted by FDA, EMA, MHRA, PMDA, and other Health Authorities.  

• Conduct inspection readiness assessments, mock inspections, document reviews, and interview coaching activities.  

• Support hosting and management of regulatory inspections and serve as a key quality representative during inspection activities.  

• Ensure timely and effective responses to regulatory observations, inspection findings, and commitments.