Clinical Quality Assurance, Specialist II

Role: Clinical Quality Assurance Specialist supporting GCP compliance within Arrowhead's biopharma operations, primarily focusing on clinical trial quality and regulatory adherence. Responsibilities: develop and maintain risk-based quality plans, support audits and inspections, manage quality events (non-conformances, CAPAs, deviations), review SOPs, track metrics, facilitate continuous quality improvement, and communicate risks to senior management. Requirements: Bachelor's in science, 3+ years in regulated environments with GCP and QA experience, strong knowledge of GCP, FDA, EMA, ICH guidelines; proficiency with Veeva, MS Office; ability to support audits and inspections. Preferred: experience with electronic document management systems (Veeva), AI knowledge. High-Value: GCP compliance, clinical trial quality, regulatory inspections, risk management, cross-functional collaboration. Work setup: occasional travel to Arrowhead locations in San Diego, Verona, and Pasadena.