• Ensure GCP compliance with ImmunityBio entity standard operating procedures, ICH and US FDA regulations and guidelines, and clinical study protocols • Interact cross-functionally with functional teams in Clinical Trials including Clinical Operations, Regulatory, Pharmacovigilance, Medical Writing and Data Management to ensure compliance to the GCP Quality Management System and all applicable regulatory requirements • Maintain and update the Clinical Trial Quality Management system to be current with industry standards, guidance, and best practices • Contribute to the development and review of SOPs and other controlled documents • Ensure compliance with SOPs and ICH GCP E6 (R2) standards • Manage the incident management program through monitoring of complaints, deviations and CAPAs • Schedule, plan, coordinate, and conduct audits (vendor/supplier audits, internal audits, compliance visits, for cause audits and clinical trial site audits) • Prepare required documentation to support audit activities • Validate accuracy of audit findings and ensure satisfactory resolution of non-compliance issues • Review trial related documents e.g. protocols, protocol amendments, ICFs, pharmacy manuals and CSRs • Participate in solving GCP compliance issues within Quality Assurance, Clinical Operations, Regulatory Affairs, Medical Affairs, and Pharmacovigilance • Support training on company procedures, GCP regulations, and documentation systems • Maintain QA department spreadsheets tracking deviations, CAPAs, complaints, audit findings, and audit files