Manager, Clinical Quality Assurance Auditor

The Position

This position will lead and participate in Good Clinical Practice, Good Laboratory Practice, Good Pharmacovigilance (GCP/GLP/GVP) audits for clinical research involving pharmaceutical products, including compliance oversight and coordination of the Vendor Qualifications and Clinical Site Audit programs within Quality Assurance. Audit types will include leading audits of clinical investigator sites, vendors, systems/processes, and clinical documents to ensure that Arrowhead is meeting its regulatory GCP and applicable regulatory requirements. This position will be involved in issue management, non-conformances, deviations, and corrective/preventive actions (CAPAs), including generation of risk-based audit plans for vendor, system, and clinical site audits. In addition, this position is responsible for the provision of consultation and advice with respect to GCP to R&D and other relevant internal business partners.

Responsibilities

• Independently conduct Clinical Investigator Site Audits, Vendor, Internal System Audits, GCP/GxP Document Audits (Clinical Study Reports and Trial Master Files)

• Manage a vendor/site audit tracking system, and assist with planning and scheduling future requalification requirements

• Author and manage Audit Plans and Audit Reports

• Facilitate ongoing quality improvement through communication of audit results, CAPAs and GCP guidance and consultation to clinical teams

• Support health authority inspections

• Communicate any serious or critical compliance risks noted from these activities to senior management (manage report of Serious Breaches)

• Participates and leads in generating, training, evaluating, and executing, as required, Arrowhead Standard Operating Procedures and Work Instructions regarding GCP/GCLP/GxP, industry guidelines (such as International Council of Harmonization-ICH) and global regulations

• Issuance, review, tracking, and completion of 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 Clinical Development on identifying and mitigating any compliance issues

• Direct contract auditors and others who oversee activities performed by contract auditors

• Ensure vendor/site audit and qualification documentation is properly maintained in Veeva electronic repositories

Requirements:

• Minimum of 5 years of relevant experience in GxP auditing and compliance

• Strong knowledge of GCP/GCLP/GVP and Food & Drug Administration (FDA), European regulations and ICH guidelines

• Prior GCP/GCLP/GVP auditing, training, and or compliance investigation experience is required.

• Minimum of a bachelor's degree in a Science discipline is required

• Requires approximately >50% travel

Preferred:

• Professional certification in clinical trial auditing is desirable (Certified Quality Auditor, American Society of Quality-ASQ or Certified Clinical Research Professional, Society of Clinical Research Associates-SoCRA)
• Knowledgeable in Computer System Validation (CSV) and data integrity audits is beneficial