Director, Supplier Quality & Audits – Strategy & Compliance

Immunome, Inc.; Bothell (WA); On-site; USD 175,100 - 239,998; Full time

Job summary

Immunome, Inc. in Bothell, WA, seeks a Director/Associate Director for Supplier Quality & Audits to lead the global supplier quality program, audits, and vendor governance across CDMOs, CROs, and external laboratories. This role ensures risk-based oversight and inspection readiness.

The ideal candidate has a scientific/technical degree, 8+ years in biopharma with GxP oversight, relevant audits/certifications, and the ability to travel up to 20% domestically and internationally.

Qualifications

• Bachelor’s degree in a scientific, technical, or related field.
• 8+ years of biopharmaceutical industry experience, including direct oversight of third parties performing GxP activities, cGMP manufacturing, testing, or clinical operations, or equivalent experience.
• Demonstrated experience performing and managing supplier qualification and supplier audit programs.
• Experience supporting virtual, outsourced, or external manufacturing and service provider models preferred.
• Ability to travel domestically and internationally up to 20%, with occasional evening/weekend commitment to support audits and inspections.
• Professional certifications (e.g., ASQ CQA, CMQ/OE, RQAP, ISO 9001/13485 Lead Auditor, RAC) or equivalent quality/auditing/regulatory certifications are highly desirable.

Responsibilities

• 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.
• Plan and conduct supplier audits and follow-up, including responses, CAPAs, and effectiveness checks.
• Support inspection readiness for outsourced GxP operations, including regulatory and internal audit preparation.
• Monitor supplier quality performance, including deviations, CAPAs, complaints, audit findings, and service-level trends.
• Identify, escape, 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.
• Support continuous improvement of supplier quality, oversight, audit effectiveness, and inspection readiness.

Skills

Supplier Quality Management

GxP auditing

Quality Systems

Regulatory compliance

Vendor governance

Auditor training

Education

Bachelor's degree in science/technical

Advanced degree preferred

Job description

Immunome, Inc. in Bothell, WA, seeks a Director/Associate Director for Supplier Quality & Audits to lead the global supplier quality program, audits, and vendor governance across CDMOs, CROs, and external laboratories. This role ensures risk-based oversight and inspection readiness.

The ideal candidate has a scientific/technical degree, 8+ years in biopharma with GxP oversight, relevant audits/certifications, and the ability to travel up to 20% domestically and internationally.