The Position

The Manager, Clinical Quality Assurance position will develop and implement clinical quality management strategies in compliance with Good Clinical Practice, oversee and ensure GCP standards across all clinical trials and studies, review and assess clinical trial documentation, including quality risk plans, SOPs and study reports. Serves as subject matter expert on GCP and quality management and initiates and works with stakeholders on quality issues.

Responsibilities

• Develop and maintain clinical quality study risk plans and maintain updates in Quality Management System
• Share with functional QA leads risk plans and updates
• Collect site metrics for selection of investigator site audits
• Implement and update investigator site audit annual plans
• Participate in program and protocol team meetings as the QA representative
• Leads and coordinates QA to QA relationship with CROs and collects metrics for review
• Analyzing and reporting trends in audit findings
• Facilitate ongoing quality improvement through communication of audit results, CAPAs and GCP guidance and consultation to clinical teams
• Issuance, review, tracking, and completion of deviations, SCARs (supplier corrective action requests) and CAPAs
• Provide support for clinical study programs with GCP compliance, as needed
• 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
• Keep up to date with all related quality legislation and compliance issues. Ensure regulations are communicated through development of corporate policies and procedures
• Assist in document management and training functions across GxP areas as needed

Requirements:

• Minimum of a bachelor's degree in a Science discipline
• Minimum of 5 years of relevant experience in GCP, investigator site audits and compliance
• Experience administering deviation and/or CAPA processes
• Experience authoring, reviewing, and managing controlled documents
• Strong knowledge of GCP and Food & Drug Administration (FDA), European regulations and ICH guidelines
• Requires occasional travel to other Arrowhead locations (San Diego, CA; Verona, WI; Pasadena, CA)

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)