Sr Director/Director, Quality Systems

Description

Company Overview

Immunome is a clinical-stage targeted oncology company committed to developing first- and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge targeted cancer therapies, including antibody-drug conjugate therapies (ADCs.) In addition to a portfolio of discovery-stage ADCs, our pipeline includes AL102, a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors, as well as IM-1021, a ROR1 ADC, and IM-3050, a FAP-targeted radioligand, both of which are the subject of INDs expected to be submitted in the first quarter of 2025.

Position Overview

The Senior Director/Director of Quality Systems will provide leadership and direction to ensure the development, implementation, and maintenance of a robust Quality Management System (QMS) that complies with Good Manufacturing Practices (GMP), and other applicable regulatory requirements. This position collaborates with internal and external stakeholders to ensure product quality and regulatory compliance throughout all stages of the product lifecycle, from development to commercialization.

Responsibilities

Quality Management

• Develop and execute a strategic vision for the Quality Management System, aligning it with the company's long-term objectives.
• Manage the development, implementation, and maintenance of the Quality Systems and ensure compliance with regulatory standards (FDA, EMA, ICH, etc.) and industry best practices.
• Ensure effective CAPA management, change controls, deviations, and other GMP-related processes are established. 
• Lead the maintenance and continuous improvement of the Quality Management System, including deviation, change control, CAPA, and complaint system with the goal of maximizing efficiency, effectiveness and compliance with all applicable GMP regulations.
• Lead periodic review and revision of SOPs, policies, and Quality Agreements to align with regulatory updates and business needs.
• Ensure comprehensive training programs for GMP, GCP, and quality standards are in place and effectively executed.

Documentation and Record Control

• Ensure proper management of GxP document control and records management systems, including document approval, archiving, and retrieval.
• Act as the business process owner for the company’s electronic document management system, ensuring system validation and continuous improvement.
• Implement and/or oversee the Computer System Quality Assurance & Data Integrity programs for electronic based systems ensuring compliance with 21 CFR Part 11 regulatory standards.  Ensure site is compliant with global data integrity program expectations.

Regulatory Compliance and Inspection Readiness

• Ensure the organization’s quality systems are always inspection-ready, in compliance with regulatory requirements, and prepared for GMP audits or inspections from FDA or other international regulatory bodies.
• Collaborate with regulatory affairs and cross-functional teams to support regulatory submissions, including providing necessary documentation and ensuring compliance with filing requirements.
• Ensure Quality Agreements are properly stored and managed.
• Support site preparation for regulatory inspections including personnel preparation and training

Operational Leadership and Continuous Improvement

• Drive continuous improvement initiatives across quality operations to enhance operational efficiency, reduce risk, and improve product quality.
• Provide strategic direction and hands-on leadership for quality operations teams, ensuring alignment with business goals and regulatory demands.
• Develop and implement metrics to monitor and report on the performance of Operations, identifying areas for improvement and ensuring corrective actions are implemented.
• Promote a strong Quality culture within the organization.  Identify compliance risks and be a part of the solution through ownership and collaboration.
• Oversee and monitor Quality metrics ensuring data is understandable and translatable to the appropriate audience(s), ensuring site progresses on global heatmap

Team Leadership and Development

• Mentor, coach, and develop a high-performing quality team to support the growth of the organization.
• Set performance objectives for direct reports and manage their d