Associate Director / Director, Supplier Quality and Audits

The role

This role supports the Head of GMP Quality Compliance in building and improving the Supplier Quality Compliance and Audit Program. The person will lead supplier audit management, vendor governance, and inspection readiness for GxP suppliers and service providers.

What you will do

• Support development and continuous improvement of 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.
• Support quality oversight of CDMOs, CROs, labs, consultants, and other outsourced service providers.
• Partner with stakeholders to 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.
• Monitor supplier quality performance, including deviations, CAPAs, complaints, and audit findings.
• Identify, escalate, and support remediation of supplier quality and compliance risks.

Required 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
• Ability to travel domestically and internationally up to 20%, with occasional evening/weekend commitment to support audits and inspections
• Strong knowledge of Supplier Quality Management, GxP auditing, Quality Systems, and regulatory compliance within the biotechnology or pharmaceutical industry
• Experience managing supplier qualification, governance, quality agreements, risk assessments, and oversight of CDMOs, CROs, labs, and other GxP service providers
• Demonstrated experience conducting supplier audits, managing audit programs, supporting regulatory inspections, CAPA management, and inspection readiness activities
• Proven Lead Auditor experience with strong knowledge of FDA, EU, ICH, and applicable GxP regulations
• Strong understanding of cGMP manufacturing, quality assurance/control, validation, and outsourced pharmaceutical operations
• Experience developing audit schedules, audit plans, audit reports, and auditor training programs
• Excellent organizational, communication, collaboration, negotiation, analytical, and problem-solving skills
• Ability to manage multiple priorities in a fast-paced environment and adapt effectively to changing business needs

Nice to have

• advanced degree
• Experience supporting virtual, outsourced, or external manufacturing and service provider models
• Professional certifications (e.g., ASQ CQA, CMQ/OE, RQAP, ISO 9001/13485 Lead Auditor, RAC) or equivalent quality/auditing/regulatory certifications

Benefits

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

About the company

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. The company is advancing an innovative portfolio of therapeutics, including antibody-drug conjugates.