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.
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 development through regular performance evaluations.
Qualifications
Education and Experience
- Bachelor’s degree in life sciences, chemistry, engineering, or related field; advanced degree (MS, PhD, MBA) preferred.
- Minimum of 15 years of experience in quality assurance, quality systems and/or quality operations within the pharmaceutical, biotechnology, or life sciences industries. A minimum of 5 years of leadership experience is required.
Knowledge and Skills
- Proven experience in managing GMP operations, QMS, including vendor management and CMO oversight.
- Strong knowledge of FDA, EMA, ICH, and other global regulatory guidelines and their application to Quality Operations.
- Experience supporting clinical and commercial stage programs, with a strong understanding of the product lifecycle from development through to commercialization.
- Strong project management, organizational, and leadership skills with the ability to multitask and prioritize in a fast-paced environment.
- Excellent verbal and written communication skills, with the ability to collaborate effectively across functions and at all levels of the organization.
- Demonstrated ability to lead cross-functional teams and manage external vendors and stakeholders.
- Proficiency in using electronic QMS platforms (e.g., MasterControl, TrackWise, Dot Compliance) and Microsoft Office (Word, Excel, PowerPoint).
- Strategic thinking with a proactive approach to problem-solving and process improvement.
- Experienced with biologics and small molecule manufacturing processes.
Travel
- Position may require domestic and international travel (up to 25%).
E/E/O
Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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