Immunome, Inc.

Immunome, Inc.

Associate Director / Director, Supplier Quality & Audits

Bothell, Washington, United States · Director

Sponsorship not specifiedDetected 7 days ago
Product ManagementNegotiationAuditingVendor ManagementGMPFDA RegulatoryLeadershipInternal AuditGxP

About the role

  • 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 submitted to the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-3050, an IND-cleared FAP-targeted radiotherapy; and IM-1617, an IND-cleared solid tumor ADC. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed

Responsibilities

  • Support development and continuous improvement of Immunome's GxP Supplier Quality and Vendor Management Program.
  • Lead supplier qualification, risk classification, onboarding, and ongoing monitoring of GxP vendors and service providers.
  • Maintain supplier quality records, risk evaluations, audit reports, and performance metrics.
  • Support quality oversight of CDMOs, CROs, labs, consultants, and other outsourced service providers.
  • Partner with stakeholders to clearly define and maintain vendor responsibilities and compliance expectations.
  • Lead negotiation and lifecycle management of quality agreements.
  • Support inspection readiness for outsourced GxP operations, including regulatory and internal audit preparation.
  • Identify, escalate, and support remediation of supplier quality and compliance risks.
  • Support cross-functional vendor governance meetings and document decisions, actions, and follow-up commitments.
  • Develop and maintain supplier quality procedures, Quality Agreement templates, and related trackers and tools aligned with Immunome's Quality Management System and regulatory expectations.

Requirements

  • 8+ years of biopharmaceutical industry experience, including direct oversight of third parties performing

Nice to have

  • Bachelor's degree in a scientific, technical, or related field
  • advanced degree preferred.

Company info

  • 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.
  • We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets.
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