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.

• Work with functional teams to embed inspection readiness into routine operations rather than periodic preparation efforts.

Procedural Documentation & Compliance

• Lead the development, review, revision, approval, and implementation of Development SOPs, standards, templates, and guidance documents.

• Partner directly with process owners and subject matter experts to create practical, compliant, and scalable procedures.

• Ensure procedural documentation remains aligned with evolving regulatory requirements, industry best practices, and business needs.

• Develop and deliver training and educational programs to enhance organizational understanding of quality requirements, risk management, inspection readiness, and compliance expectations.

• Establish and communicate clear guidance regarding the role of Development QA and when functional teams should engage QA support.

• Create tools, onboarding materials, communications, and training resources that help functional teams understand Development QA services, responsibilities, and value.

• Support quality event management activities, including deviations, investigations, CAPAs, and documentation within the Quality Management System.

Vendor & CRO Management

• Support qualification, oversight, and ongoing evaluation of CROs, laboratories, pharmacovigilance providers, technology vendors, and other external partners.

• Participate in vendor risk assessments and support the establishment of appropriate oversight models.

• Review vendor performance trends, quality metrics, and compliance risks and provide recommendations for improvement actions.

• Ensure quality expectations, responsibilities, and oversight requirements are appropriately communicated and maintained throughout the vendor lifecycle.

• Act as a quality resource during vendor selection, governance, issue management, and escalation activities.

Continuous Improvement

• Partner with GMP Quality Assurance leadership to establish, implement, and continuously improve a unified enterprise Quality Management System supporting GMP, GCP, GLP, and GVP activities.

• Drive harmonization and simplification of quality processes across Development and Manufacturing organizations while meeting applicable regulatory requirements.

• Facilitate quality risk assessments and support Development teams in proactively identifying, escalating, and mitigating compliance risks.

• Develop and maintain risk registers, quality dashboards, and metrics that provide visibility into organizational quality performance and emerging risks.

• Support Serious Breach assessments, significant protocol deviations, quality event investigations, and related compliance activities.

• Identify and implement continuous improvement initiatives that enhance operational efficiency, compliance effectiveness, and inspection readiness.

• Evaluate, implement, and leverage emerging technologies, including Artificial Intelligence (AI) and Machine Learning (ML), to improve the efficiency, effectiveness, and scalability of Development Quality processes.

• Partner with Quality, Clinical Development, and Technology teams to identify opportunities for AI-enabled automation of quality workflows, document management, SOP lifecycle activities, training management, quality reporting, and risk monitoring.

• Ensure AI-enabled solutions are appropriately governed, risk-assessed, and implemented in accordance with company procedures and applicable regulatory expectations.

• Apply data analytics and predictive quality approaches to identify trends, detect emerging risks, and support proactive quality oversight.

Qualifications

• Bachelor's or Master's degree in Chemistry, Biochemistry, Clinical Pharmacology, Life Sciences, or related field.

• Minimum of 15 years of experience in biotechnology, pharmaceutical, or life sciences, quality assurance, clinical development, or related GxP-regulated environments.

• Minimum of 5 years of leadership experience managing quality professionals and supporting quality systems, inspection readiness, compliance programs, and quality oversight activities.

• Demonstrated experience building, implementing, or improving Quality Management Systems and quality processes.

• Significant experience supporting global clinical development programs and regulatory inspections.

• Experience with biologics, antibody-drug conjugates (ADCs), radiopharmaceuticals, and/or small molecule development preferred.

Knowledge and Skills

• Deep knowledge of GCP, GLP, GVP, FDA, EMA, ICH guidelines, and global regulatory requirements applicable to clinical development.

• Strong understanding of risk-based quality management principles, inspection readiness, and Quality Management System processes.

• Experience developing, reviewing, and implementing SOPs, standards, guidance documents, and quality system processes.

• Demonstrated success partnering with Clinical Operations, Clinical Development, Pharmacovigilance, Regulatory Affairs, and external partners to improve quality and compliance outcomes.

• Experience supporting Health Authority inspections, Serious Breach assessments, quality event investigations, CAPA management, and risk management activities.

• Strong communication skills with the ability to influence, coach, train, and collaborate effectively across a global, cross-functional organization.

• Excellent analytical, organizational, and problem-solving abilities with a demonstrated capability to assess risk and provide practical recommendations.

• Strong project management, change management, and organizational effectiveness skills.

• Experience developing quality metrics, dashboards, and management reporting tools.

• Proficiency with electronic Quality Management Systems and quality documentation platforms such as TrackWise, MasterControl, Veeva Quality, or equivalent systems.

• Demonstrated ability to leverage technology, automation, AI, and advanced analytics to improve quality processes and operational efficiency.