Senior Director, Development Quality Assurance

The posting, as Immunome, Inc. wrote it

Company Overview

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugates. Our pipeline includes varegacestat, an investigational gamma secretase inhibitor for which an NDA has been accepted by the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-1617, a clinical-stage solid tumor ADC; and IM-3050, a clinical-stage FAP-targeted radioligand therapy. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets.

Position Overview

The Senior Director, Development Quality Assurance (DQA) is responsible for implementing and executing quality assurance strategies that support Immunome's clinical development activities and ensure compliance with applicable Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practice (GVP), and global regulatory requirements (FDA, EMA, ICH, etc.).

Reporting to the Vice President, Head of Development Quality Assurance, this role serves as a key quality partner to Clinical Development, Clinical Operations, Pharmacovigilance, Regulatory Affairs, Biometrics, Medical Writing, and other Development functions. The Senior Director collaborates closely with functional teams to identify and mitigate risk, develop compliant and efficient processes, strengthen inspection readiness, and build organizational quality capabilities.

The Senior Director will help establish and maintain a fit-for-purpose Quality Management System (QMS), drive quality culture throughout the organization, and provide expertise, guidance, training, and partnership to support successful execution of Immunome's development programs. The role emphasizes proactive quality oversight, continuous improvement, risk-based decision-making, and inspection readiness while utilizing audits as one component of a broader quality assurance framework.

Responsibilities

Leadership & Quality Strategy

• Execute Development QA objectives and priorities established by the VP, Head of Development Quality Assurance.
• Partner with Development functional leaders to promote a culture of quality, compliance, accountability, patient safety, and continuous improvement.
• Serve as a trusted advisor and quality business partner across Clinical Development, Clinical Operations, Regulatory Affairs, Pharmacovigilance, Biometrics, and related functions.
• Provide quality guidance and recommendations to leadership regarding quality risks, compliance issues, inspection readiness, and process improvements.
• Develop and maintain quality metrics, risk indicators, and dashboards to support data-driven decision making and management oversight.
• Champion innovative approaches, including Artificial Intelligence (AI

[…]
rated capability to assess risk and provide practical recommendations.

• Strong project management, change management, and organizational effectiveness skills.
• Experience developing quality metrics, dashboards, and management reporting tools.
• Proficiency with electronic Quality Management Systems and quality documentation platforms such as TrackWise , MasterControl , Veeva Quality, or equivalent systems.
• Demonstrated ability to leverage technology, automation, AI, and advanced analytics to improve quality processes and operational efficiency.

Washington State Pay Range
$260,000 — $293,977 USD

Join Our Experienced, Passionate Team

Working at Immunome gives you the opportunity to make a difference in the lives of cancer patients, contribute to developing best-in-class targeted cancer therapies, and work with some of the brightest and most experienced minds in antibody-drug conjugate (ADC) development.

Immunome’s office is charged with the collective excitement and passion of people working together to develop life-changing cancer medicines. Our team thrives in an innovative, collaborative environment where employees are empowered to do their best work.

Immunome also offers a comprehensive benefit program for you and your family, including:

• Medical, dental, and vision insurance coverage for employees and their dependents, including 100% company-paid medical premiums for employees
• A 401(k) with employer match
• Employer-paid life insurance, short- and long-term disability insurance, and AD&D
• Paid time off, company holidays, and a week-long winter break between Christmas and New Years.
• Paid parental leave

E/E/O

Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

E-Verify

Immunome, Inc. is a participant in E-Verify. Please review the following notices: E-Verify Participation Poster | Right to Work Poster (English) | Right to Work Poster (Spanish) .