Lead Supplier Auditor

Responsibilities

• Independently conduct Vendor Audits, Internal System Audits, and Clinical Trial Site audits, including issuing timely reports and facilitating finding responses
• Assist in generation, tracking, monitoring, and reporting of key quality metrics
• Facilitate ongoing quality improvement through communication of audit results, CAPAs and GxP guidance to the Quality and Business teams
• Support health authority inspections
• Communicate any serious or critical compliance risks noted from these activities to senior management (manage report of Critical Findings)
• Participate and lead in the lifecycle of Arrowhead Standard Operating Procedures and Work Instructions regarding GxP, industry guidelines, and global regulations
• Assist in the issuance, review, tracking, and completion of Quality Events (e.g. deviations and CAPAs)
• Keep up to date with all related quality legislation and compliance issues. Ensure regulations are communicated through development of corporate policies and procedures
• Work with Vendor Management Teams on identifying and mitigating any compliance issues
• Oversee contract auditors and others perform audits on behalf of Arrowhead
• Ensure vendor/site audit and qualification documentation is properly maintained in Veeva electronic repositories

Requirements

• Bachelor’s degree in a science discipline is required
• 5 years of relevant experience in GxP auditing and compliance
• Strong knowledge of GMP/GLP/GDP/GCP/GVP and Food & Drug Administration (FDA), European regulations and ICH guidelines
• Prior GMP/GLP/GCP/GCP/GVP auditing, training, and/or compliance investigation experience
• Knowledgeable in Computer System Validation (CSV) and data integrity audits is beneficial

Qualifications

• Requires travel to other Arrowhead locations as well as domestic and international travel

Benefits

California pay range: $105,000 USD - $125,000 USD

Arrowhead provides competitive salaries and an excellent benefit package.

All applicants must have authorization to work in the US for a company.

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