Clinical Quality Assurance, Specialist II

Role: Clinical Quality Assurance Specialist supporting GCP compliance and quality activities at Arrowhead Pharmaceuticals. Responsibilities: develop and maintain clinical risk plans, support audits and inspections, manage quality events (non-conformances, CAPAs, deviations), review SOPs, track metrics and trends, and facilitate continuous quality improvement through cross-functional communication. Requirements: Bachelor's in science; 3+ years in regulated environments with GCP quality assurance experience; strong knowledge of GCP, FDA, EMA, and ICH guidelines; proficiency in Veeva, MS Office; willingness to travel occasionally. Preferred: experience with electronic document systems (Veeva) and knowledge of AI model training. High-value: focus on clinical GCP compliance, audit support, risk management, and inspection readiness within a biopharma setting. Work setup: location-based in California with travel to other sites as needed.