Lead Supplier Auditor

The Position

This position will lead and participate in vendor audits for Arrowhead in accordance with GxP and/or other applicable regulations. Support the vendor qualification management team with qualification records, and may assist with quality events, procedural document review, and inspection readiness.

• Independently conduct Vendor Audits, Internal System Audits, and Clinical Trial Site audits; issue timely reports and facilitate finding responses
• Generate, track, monitor, and report key quality metrics
• Communicate audit results, CAPAs, and GxP guidance to Quality and Business teams to drive quality improvement
• Support health authority inspections
• Communicate serious/critical compliance risks to senior management (manage report of Critical Findings)
• Participate and lead the lifecycle of SOPs and Work Instructions related to GxP, industry guidelines, and global regulations
• Assist with issuance, review, tracking, and completion of Quality Events (deviations and CAPAs)
• Stay current on quality legislation/compliance; ensure communication via corporate policies/procedures
• Work with Vendor Management Teams to identify and mitigate compliance issues
• Oversee contract auditors and others performing audits on Arrowhead’s behalf
• Maintain vendor/site audit and qualification documentation in Veeva electronic repositories

• Bachelor’s degree in a science discipline
• 5 years of relevant GxP auditing and compliance experience
• Strong knowledge of GMP/GLP/GDP/GCP/GVP and FDA, European regulations, and ICH guidelines
• Prior GMP/GLP/GCP/GVP auditing, training, and/or compliance investigation experience
• CSV and data integrity audit knowledge beneficial
• Travel to other Arrowhead locations and domestic/international travel required
• All applicants must have authorization to work in the US for a company.