Director of Clinical Quality Assurance

The Director of Clinical Quality Assurance is responsible for supporting the strategy for Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and Good Laboratory Practices (GLP) quality oversight at Immunome. The individual will partner with QA leadership and stakeholders to ensure phase-appropriate QA support and audits are executed for Immunome pre-clinical, clinical and pharmacovigilance programs in compliance with applicable regulations, ICH guidelines, and industry best practices.

Key Responsibilities

• Provide overall Clinical QA support for internal clinical and pharmacovigilance teams.
• Lead and conduct GCP, GLP and GVP audits of internal processes, investigator sites and external vendors (e.g., CROs, laboratories, etc.).
• Manage vendor qualification processes, ensuring proper oversight through vendor assessments, contract reviews, and vendor audit reports.
• Provide regular updates to QA leadership on audit progress and findings, ensuring CAPAs are implemented effectively and timely.
• Track audit findings, manage audit responses, and generate audit reports, providing key insights into compliance trends and areas for improvement.
• Support and participate in regulatory inspections readiness activities as well as inspections (FDA, EMA, etc.) related to clinical trials and pharmacovigilance activities.
• Ensure timely responses to regulatory authorities and audit observations, facilitating CAPAs as required.
• Develop, review, and maintain department SOPs as well as clinical quality procedural documents to ensure compliance with GCP, GLP, and GVP regulations.
• Oversee the qualification and management of CROs, investigator sites and other external vendors, ensuring their compliance with GCP, GLP, GVP, and contractual obligations.
• Identify and support the implementation of continuous improvement initiatives across clinical QA processes to enhance operational efficiency and maintain high compliance standards.
• Participate in cross-functional quality improvement projects, supporting clinical operations in improving trial processes and outcomes.
• Partner cross-functionally to enable transparency and escalation of development quality risks and issues, collaborating to address challenges and constraints.
• Serve as a resource to pre-clinical, clinical and pharmacovigilance teams on compliance issues and regulatory risks.