Sr Director/Director, Quality Operations

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 Operations will play a pivotal role in ensuring the highest standards of quality and compliance are executed across all aspects of operations. 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. 

The Director/Senior Director of Quality Operations is responsible for developing and leading quality programs for both commercial and clinical manufacturing operations, ensuring compliance with global regulatory standards. This role interacts with executive leadership to communicate quality initiatives, issues, and resource requirements, ensuring alignment with corporate compliance goals. The position oversees quality assurance (QA) activities across multiple functional areas and manufacturing sites, leads internal and external audits, and drives continuous improvement in quality systems.

Responsibilities

Quality Operations

• Oversee the drug substance, drug product, packaging/labeling/serialization, third party logistics.
• Review and approve specifications affecting product quality and oversee the development of master batch records, process and method validation/protocol reports and other technical documents created to support all stages of the product lifecycle, from development to commercialization.
• Disposition early phase and commercial batches.
• Ensure effective CAPA management, change controls, deviations, and other GMP-related processes are followed during manufacturing and testing of products. 
• Interact with manufacturing, clinical, or other functional areas that impact quality operations and provide support as needed.
• Perform risk assessments and implement appropriate quality and process controls to ensure proper oversight of production activities.
• Support vendor qualification program and monitor vendor performance.
• Prompt communication to management of potential compliance issues.
• Participate in internal and external project team meetings.

Documentation and Record Control

• Perform periodic reviews and revisions of SOPs, policies, and Quality Agreements to align with regulatory updates and business needs.
• Establish, review and/or approve Quality Agreements and ensure they are properly stored and managed.

Regulatory Compliance and Inspection Readiness

• Ensure external parties are 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.
• Support site preparation for regulatory inspections including personnel preparation and training
• Participate in Quality Management Review meetings.
• Assist in updating CMC sections of regulatory and quality documents

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 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.