Immunome, Inc.
Sr. Manager, Quality Management Systems
Immunome, Inc. - Bothell, Washington, United States, 98021
Work at Immunome, Inc.
Overview
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Overview
Immunome is a clinical-stage targeted oncology company committed to developing first-in-class 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). Our most advanced pipeline programs are varegacestat (formerly AL102), a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors; IM-1021, a ROR1-targeted ADC which is currently in a Phase 1 trial; and IM-3050, a FAP-targeted radioligand, which recently received IND clearance. Our pipeline also includes IM-1617, IM-1335, and IM-1340, all of which are preclinical ADCs pursuing undisclosed targets with expression in multiple solid tumors.
Qualifications, skills, and all relevant experience needed for this role can be found in the full description below. Position Overview The Sr. Manager, Quality Management Systems will play a key leadership role in the design, deployment, and continuous improvement of Immunome’s Quality Management System (QMS). Reporting to the Head of Quality Systems, this role will be responsible for ensuring the effective implementation and oversight of core quality system elements, including GxP document control, records management, and training administration. This position requires cross-functional collaboration and vendor oversight to support quality and regulatory compliance from early development through commercialization. Responsibilities Document Control & Records Management Serve as the process owner for GxP-controlled document and records management. Develop, implement, and maintain SOPs, templates, and controlled workflows in the electronic Document Management System (eDMS/eQMS). Ensure controlled documents (e.g., SOPs, policies, Quality Agreements) are current, reviewed periodically, and updated to reflect regulatory and business changes. Lead ongoing system optimization efforts to ensure scalability and usability of the document control platform. Provide quality oversight for manufacturing and quality records supporting GxP operations. GxP Training Program Administration Serve as the owner of GxP training processes and systems. Define and maintain training requirements and curricula for GxP personnel in collaboration with functional area leads. Develop and deliver training for system users and support integration of off-the-shelf content where applicable. Oversee assignment, tracking, and reporting of training compliance through the eQMS. Support development of training effectiveness strategies in collaboration with functional leads. Quality System Leadership & Oversight Contribute to the strategic direction of Immunome’s Quality Systems function. Identify and implement process improvements to enhance system efficiency and compliance. Define and monitor quality metrics and KPIs to measure the health of Document Control and Training programs. Support inspection readiness activities, including document retrieval and system demonstration during audits and regulatory inspections. Perform and lead continuous improvement initiatives to enhance the maturity and effectiveness of Immunome’s Quality Systems. Serve as SME during audits and regulatory inspections, including retrieval of GxP documents and training records. Support Quality Management Review with data on system performance, training compliance, and document lifecycle health. Collaborate with IT, Regulatory, Clinical, and Technical Operations teams to ensure QMS alignment across all GxP functions. Other Participate in the implementation and configuration of additional QMS modules as Immunome’s quality infrastructure evolves. Support other compliance and quality initiatives as assigned. Qualifications Bachelor’s degree in life sciences or equivalent A minimum of 7 years of experience in a regulated biotechnology or pharmaceutical company; minimum 3 years of primary experience in QMS and/or Document and Training Administration Excellent proficiency in Microsoft Applications, especially MS Word. Knowledge and Skills Proven experience in setting up and managing validated GxP Document Management and Training Systems, including oversight of vendor relationships. Proficiency with electronic QMS platforms (e.g., MasterControl, TrackWise, Dot Compliance) and Microsoft Office applications (Word, Excel, PowerPoint). Expertise in designing, maintaining, and administering GxP training programs, with a strong interest in and ability to develop and/or deliver training content. In-depth knowledge of data integrity principles and their practical application in the management of EDMS/eQMS. Strong continuous improvement mindset with a proactive, solution-oriented approach to system optimization and process enhancement. Solid understanding of FDA, EMA, ICH, and other global regulatory requirements related to document control and training compliance. Experience supporting both clinical and commercial-stage programs, with a thorough understanding of the product lifecycle from development through commercialization. Excellent project management, organizational, and leadership skills, with the ability to multitask and manage priorities in a fast-paced, evolving environment. Outstanding verbal and written communication skills; able to influence and collaborate effectively across all levels and functions within the organization. Demonstrated success in leading or contributing to cross-functional initiatives, including the management of external vendors and service providers. Experience with biologics and ADCs is desirable; familiarity with small molecule operations is a plus. Washington State Pay Range $161,553 - $189,823 USD E/E/O Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Create a Job Alert Interested in building your career at Immunome, Inc.? Get future opportunities sent straight to your email. Apply for this job * indicates a required field First Name * Last Name * Preferred First Name Email * Phone Resume/CV * Enter manually Accepted file types: pdf, doc, docx, txt, rtf Enter manually Accepted file types: pdf, doc, docx, txt, rtf Education Degree Select... Select... Select... Are you currently or have you ever been excluded or debarred by the OIG, DOJ, FDA, or any other Federal or State agency? * Select... Are you subject to a non-compete or other restrictive covenant with your current or former employer that bars you from employment at Immunome? * Select... Do you live within daily commuting distance of Bothell, WA or are you willing to relocate? * Yes, I live within daily commuting distance of Bothell, WA. Yes, I am willing to relocate. No, but I am willing to travel weekly. No, I do not live within daily commuting distance of Bothell, WA, I am not willing to relocate, and I am not willing to travel weekly. Will you now or in the future require the company to commence (“sponsor”) an immigration case to employ you (for example, H-1B or other employment-based immigration case)? This is sometimes called “sponsorship” for an employment-based visa status. * Yes, I will now, and in the future, require the company to commence (“sponsor”) an immigration case to employ me. No, I will not now, but yes in the future, require the company to commence (“sponsor”) an immigration case to employ me. No, I will not now, nor in the future, require the company to commence (“sponsor”) an immigration case to employ me. Are you authorized to work lawfully in the United States for the company? * Yes, I am authorized to work lawfully in the United States for the company. No, I am not authorized to work lawfully in the United States for the company.
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Qualifications, skills, and all relevant experience needed for this role can be found in the full description below. Position Overview The Sr. Manager, Quality Management Systems will play a key leadership role in the design, deployment, and continuous improvement of Immunome’s Quality Management System (QMS). Reporting to the Head of Quality Systems, this role will be responsible for ensuring the effective implementation and oversight of core quality system elements, including GxP document control, records management, and training administration. This position requires cross-functional collaboration and vendor oversight to support quality and regulatory compliance from early development through commercialization. Responsibilities Document Control & Records Management Serve as the process owner for GxP-controlled document and records management. Develop, implement, and maintain SOPs, templates, and controlled workflows in the electronic Document Management System (eDMS/eQMS). Ensure controlled documents (e.g., SOPs, policies, Quality Agreements) are current, reviewed periodically, and updated to reflect regulatory and business changes. Lead ongoing system optimization efforts to ensure scalability and usability of the document control platform. Provide quality oversight for manufacturing and quality records supporting GxP operations. GxP Training Program Administration Serve as the owner of GxP training processes and systems. Define and maintain training requirements and curricula for GxP personnel in collaboration with functional area leads. Develop and deliver training for system users and support integration of off-the-shelf content where applicable. Oversee assignment, tracking, and reporting of training compliance through the eQMS. Support development of training effectiveness strategies in collaboration with functional leads. Quality System Leadership & Oversight Contribute to the strategic direction of Immunome’s Quality Systems function. Identify and implement process improvements to enhance system efficiency and compliance. Define and monitor quality metrics and KPIs to measure the health of Document Control and Training programs. Support inspection readiness activities, including document retrieval and system demonstration during audits and regulatory inspections. Perform and lead continuous improvement initiatives to enhance the maturity and effectiveness of Immunome’s Quality Systems. Serve as SME during audits and regulatory inspections, including retrieval of GxP documents and training records. Support Quality Management Review with data on system performance, training compliance, and document lifecycle health. Collaborate with IT, Regulatory, Clinical, and Technical Operations teams to ensure QMS alignment across all GxP functions. Other Participate in the implementation and configuration of additional QMS modules as Immunome’s quality infrastructure evolves. Support other compliance and quality initiatives as assigned. Qualifications Bachelor’s degree in life sciences or equivalent A minimum of 7 years of experience in a regulated biotechnology or pharmaceutical company; minimum 3 years of primary experience in QMS and/or Document and Training Administration Excellent proficiency in Microsoft Applications, especially MS Word. Knowledge and Skills Proven experience in setting up and managing validated GxP Document Management and Training Systems, including oversight of vendor relationships. Proficiency with electronic QMS platforms (e.g., MasterControl, TrackWise, Dot Compliance) and Microsoft Office applications (Word, Excel, PowerPoint). Expertise in designing, maintaining, and administering GxP training programs, with a strong interest in and ability to develop and/or deliver training content. In-depth knowledge of data integrity principles and their practical application in the management of EDMS/eQMS. Strong continuous improvement mindset with a proactive, solution-oriented approach to system optimization and process enhancement. Solid understanding of FDA, EMA, ICH, and other global regulatory requirements related to document control and training compliance. Experience supporting both clinical and commercial-stage programs, with a thorough understanding of the product lifecycle from development through commercialization. Excellent project management, organizational, and leadership skills, with the ability to multitask and manage priorities in a fast-paced, evolving environment. Outstanding verbal and written communication skills; able to influence and collaborate effectively across all levels and functions within the organization. Demonstrated success in leading or contributing to cross-functional initiatives, including the management of external vendors and service providers. Experience with biologics and ADCs is desirable; familiarity with small molecule operations is a plus. Washington State Pay Range $161,553 - $189,823 USD E/E/O Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Create a Job Alert Interested in building your career at Immunome, Inc.? Get future opportunities sent straight to your email. Apply for this job * indicates a required field First Name * Last Name * Preferred First Name Email * Phone Resume/CV * Enter manually Accepted file types: pdf, doc, docx, txt, rtf Enter manually Accepted file types: pdf, doc, docx, txt, rtf Education Degree Select... Select... Select... Are you currently or have you ever been excluded or debarred by the OIG, DOJ, FDA, or any other Federal or State agency? * Select... Are you subject to a non-compete or other restrictive covenant with your current or former employer that bars you from employment at Immunome? * Select... Do you live within daily commuting distance of Bothell, WA or are you willing to relocate? * Yes, I live within daily commuting distance of Bothell, WA. Yes, I am willing to relocate. No, but I am willing to travel weekly. No, I do not live within daily commuting distance of Bothell, WA, I am not willing to relocate, and I am not willing to travel weekly. Will you now or in the future require the company to commence (“sponsor”) an immigration case to employ you (for example, H-1B or other employment-based immigration case)? This is sometimes called “sponsorship” for an employment-based visa status. * Yes, I will now, and in the future, require the company to commence (“sponsor”) an immigration case to employ me. No, I will not now, but yes in the future, require the company to commence (“sponsor”) an immigration case to employ me. No, I will not now, nor in the future, require the company to commence (“sponsor”) an immigration case to employ me. Are you authorized to work lawfully in the United States for the company? * Yes, I am authorized to work lawfully in the United States for the company. No, I am not authorized to work lawfully in the United States for the company.
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