Immunome, Inc.
Sr Director/Director, Quality Systems
Immunome, Inc., Bothell, Washington, United States, 98021
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 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.
Skills and Competencies
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.
E/E/O
Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
#J-18808-Ljbffr
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 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.
Skills and Competencies
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.
E/E/O
Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
#J-18808-Ljbffr