Senior Director, GxP Supplier Quality & Audit

Immunome, Inc.; Bothell (WA); Hybrid; USD 175,000 - 240,000; Full time

Job summary

Immunome, Inc. in Bothell, WA, seeks an Associate Director/Director of Supplier Quality and Audits to lead the GxP supplier quality program across outsourced partners.

The role oversees qualification, audits, CAPA, and risk management for CDMOs, CROs, labs, and consultants within Immunome’s QMS. You will partner with Quality Operations to ensure inspection readiness and regulatory alignment, while maintaining governance and continuous improvement across the product lifecycle.

Qualifications

• Bachelor’s degree in a scientific, technical, or related field.
• 8+ years of biopharmaceutical industry experience with GxP activities and third-party oversight.
• Experience managing supplier qualification and supplier audits.
• Experience supporting virtual/outsourced manufacturing models.
• Ability to travel up to 20% domestically and internationally.
• Professional certifications (e.g., ASQ CQA, CMQ/OE, RAC) are highly desirable.

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 outsourced providers.
• Define vendor responsibilities and ensure compliance expectations with stakeholders.
• Lead negotiation and lifecycle management of quality agreements.
• Plan and conduct supplier audits and follow-up with CAPAs.
• Support inspection readiness for outsourced GxP operations and regulatory audits.
• Monitor supplier quality performance and audit findings.
• Identify and remediate supplier quality and compliance risks.
• Support cross-functional vendor governance meetings and document decisions.
• Develop and maintain supplier quality procedures and templates aligned with QMS.

Skills

Supplier Quality

GxP Auditing

Regulatory Compliance

CAPA Management

Audit Programs

Vendor Governance

Lead Auditor

Education

Bachelor’s degree in a scientific, technical, or related field

Advanced degree preferred

Job description

Immunome, Inc. in Bothell, WA, seeks an Associate Director/Director of Supplier Quality and Audits to lead the GxP supplier quality program across outsourced partners.

The role oversees qualification, audits, CAPA, and risk management for CDMOs, CROs, labs, and consultants within Immunome’s QMS. You will partner with Quality Operations to ensure inspection readiness and regulatory alignment, while maintaining governance and continuous improvement across the product lifecycle.