Associate Director / Director, Supplier Quality and Audits
Immunome, Inc.
August 07, 2026
Remote
United States
Operations
Position Overview
Director / Associate Director, Supplier Quality and Audits supports development and continuous improvement of Immunome’s GxP Supplier Quality Compliance and Audit Program. Leads supplier audit management, vendor governance, compliance monitoring, risk management, quality agreements, CAPA management, and inspection readiness for GxP suppliers and service providers.
Responsibilities
- Support development and continuous improvement of the GxP Supplier Quality and Vendor Management Program.
- Lead supplier qualification, risk classification, onboarding, and ongoing monitoring of GxP vendors.
- Maintain supplier quality records, risk evaluations, audit reports, and performance metrics.
- Provide quality oversight of CDMOs, CROs, labs, consultants, and other outsourced providers.
- Define and maintain vendor responsibilities and compliance expectations.
- Lead negotiation and lifecycle management of quality agreements.
- Plan and conduct supplier audits and follow-up, including CAPAs and effectiveness checks.
- Support inspection readiness for outsourced GxP operations.
- Monitor supplier performance (deviations, CAPAs, complaints, audit findings, service-level trends).
- Identify, escalate, and support remediation of supplier quality/compliance risks.
- Support vendor governance meetings and document decisions and follow-ups.
- Develop/maintain supplier quality procedures, Quality Agreement templates, and related tools.
Qualifications
- Bachelor’s degree in a scientific/technical/related field (advanced degree preferred).
- 8+ years biopharmaceutical industry experience overseeing third parties performing GxP activities, cGMP manufacturing/testing, or clinical operations.
- Demonstrated experience managing supplier qualification and supplier audit programs.
- Experience with virtual/outsourced external manufacturing/service provider models (preferred).
- Travel up to 20%.
- Highly desirable certifications: ASQ CQA, CMQ/OE, RQAP, ISO 9001/13485 Lead Auditor, RAC (or equivalent).
Director / Associate Director, Supplier Quality and Audits supports development and continuous improvement of Immunome’s GxP Supplier Quality Compliance and Audit Program. Leads supplier audit management, vendor governance, compliance monitoring, risk management, quality agreements, CAPA management, and inspection readiness for GxP suppliers and service providers.
Responsibilities
- Support development and continuous improvement of the GxP Supplier Quality and Vendor Management Program.
- Lead supplier qualification, risk classification, onboarding, and ongoing monitoring of GxP vendors.
- Maintain supplier quality records, risk evaluations, audit reports, and performance metrics.
- Provide quality oversight of CDMOs, CROs, labs, consultants, and other outsourced providers.
- Define and maintain vendor responsibilities and compliance expectations.
- Lead negotiation and lifecycle management of quality agreements.
- Plan and conduct supplier audits and follow-up, including CAPAs and effectiveness checks.
- Support inspection readiness for outsourced GxP operations.
- Monitor supplier performance (deviations, CAPAs, complaints, audit findings, service-level trends).
- Identify, escalate, and support remediation of supplier quality/compliance risks.
- Support vendor governance meetings and document decisions and follow-ups.
- Develop/maintain supplier quality procedures, Quality Agreement templates, and related tools.
Qualifications
- Bachelor’s degree in a scientific/technical/related field (advanced degree preferred).
- 8+ years biopharmaceutical industry experience overseeing third parties performing GxP activities, cGMP manufacturing/testing, or clinical operations.
- Demonstrated experience managing supplier qualification and supplier audit programs.
- Experience with virtual/outsourced external manufacturing/service provider models (preferred).
- Travel up to 20%.
- Highly desirable certifications: ASQ CQA, CMQ/OE, RQAP, ISO 9001/13485 Lead Auditor, RAC (or equivalent).