Quality Assurance GxP Auditor

Arrowhead Pharmaceuticals, Inc.•Pasadena, CA

57d

About The Position

This position will lead and participate in vendor audits on behalf of Arrowhead in accordance with GxP and/or other applicable regulations. This position will support the vendor qualification management team with management of the qualification records for Arrowhead vendors. This position may also assist with the management of quality events, review of procedural documents, and inspection readiness.

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

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
Other duties consistent with the position as assigned from time to time