The Specialist II, Quality Compliance supports the Clinical Quality Compliance function by assisting with GCP compliance activities, vendor oversight processes, audit program administration, quality system activities, inspection readiness efforts, and continuous improvement initiatives. This role partners closely with Clinical QA, Clinical Operations, Pharmacovigilance, Biometrics, and external vendors to help maintain compliance with applicable GCP regulations, industry standards, and internal procedures. The Specialist will support the planning, coordination, execution, and follow-up of audits and quality system activities and may participate in audits under the guidance of experienced QA auditors.