• Provide independent GCP quality oversight for ongoing Phase IIb/III clinical trials. • Review study documentation for compliance with: ICH-GCP, FDA regulations (21 CFR Parts 11, 50, 54, 56, 312), Internal SOPs and quality standards. • Assess protocol deviations, quality trends, and study-level risk indicators. • Conduct remote GCP audits, including: CRO/vendor audits, TMF quality reviews, Process audits. • Support FDA inspection readiness activities, including: Gap assessments, Mock inspection preparation, CAPA review and effectiveness checks. • Track and trend audit findings. • Evaluate CRO quality systems and oversight documentation. • Review vendor audit reports and ensure appropriate follow-up. • Provide quality input into vendor governance processes. • Partner with Clinical Operations and functional leads to identify emerging quality risks, assess mitigation strategies, and ensure documentation supports inspection readiness. • Support development and refinement of quality metrics and KPIs. • Prepare clear, concise audit reports, develop executive summaries and quality trend reports, and maintain quality documentation tracking tools.