Lead Supplier Auditor

Scorpion Therapeutics; Pasadena (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Arrowhead is seeking a seasoned QA Auditor to lead vendor and internal system audits in a GxP-regulated environment. Collaborate with Quality and Business teams to address findings, metrics, and inspection readiness.

The role requires 5+ years of GxP auditing experience, strong GMP/GLP/GCP knowledge, and the ability to travel domestically and internationally. This position supports regulatory inspections and continuous quality improvement.

Qualifications

• Bachelor's degree in a science discipline.
• 5+ years of GxP auditing/compliance experience.
• Strong knowledge of GMP/GLP/GDP/GCP/GVP and FDA, EU regulations, and ICH guidelines.
• Prior GMP/GLP/GCP/GVP auditing or compliance experience.
• Veeva and data integrity awareness beneficial.

Responsibilities

• 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.

Skills

GxP auditing

FDA/ICH knowledge

Quality systems

Education

Bachelor's degree in a science

Tools

Veeva

Job description

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.

Responsibilities

• 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

Requirements

• 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.