Lead Supplier Auditor

Role: Lead vendor and quality system auditor supporting GxP compliance for Arrowhead's biopharma operations, primarily in gene-silencing therapeutics development. Responsibilities: conduct vendor, internal, and clinical site audits; generate and monitor quality metrics; facilitate quality improvements, CAPAs, and inspection readiness; oversee compliance documentation and vendor qualification records; support regulatory inspections; communicate risks and ensure adherence to industry regulations and GxP standards. Requirements: Bachelor's in science; 5+ years in GxP auditing and compliance; strong knowledge of GMP, GCP, GLP, GVP, FDA, EMA, ICH guidelines; prior audit experience and familiarity with CSV and data integrity beneficial. HighValue: GxP audits, vendor qualification, GxP compliance oversight, industry regulations, audit leadership, inspection support, international travel. WorkSetup: domestic and international travel required.