• Provides independent quality oversight of internal and external clinical trial activities, records, and processes to ensure compliance with FDA regulations, ICH-GCP, internal SOPs, and other applicable regulatory requirements. • Supports quality objectives across the organization and contributes to achieving departmental and company goals. • Maintains current knowledge of applicable GxP requirements and regulatory developments and communicates relevant impacts to QA leadership and stakeholders. • Supports the implementation, maintenance, and ongoing oversight of the Quality Management System (QMS). • Develops, reviews, and maintains SOPs and quality documentation to ensure compliance with applicable regulatory requirements (ICH-GCP, FDA CFR, etc.). • Provides client-facing Quality Assurance support, including development of quality documentation (e.g., SOPs, plans) and regulatory compliance guidance. • Establishes and maintains appropriate quality standards, parameters, and controls across clinical programs and quality processes. • Ensures ongoing compliance with applicable federal, state, local, and organizational regulations, guidelines, and policies. • Implements and supports Clinical Quality Assurance plans aligned with GCP standards, internal policies, and procedures. • Leads and supports inspection and audit readiness activities, including preparation, coordination, and participation in regulatory agency inspections. • Plans, conducts, and/or supports qualification, routine, and for-cause audits, and participates in the evaluation, qualification, and ongoing oversight of clinical vendors in accordance with company SOPs. • Oversees the management, tracking, and effectiveness of audit observations and CAPAs, including root cause analysis, trending, and escalation of systemic quality issues. • Evaluates quality trends and metrics to identify risks, support continuous improvement, and informs QA reporting to management. • Provides QA guidance to cross-functional teams through participation in study team meetings and interpretation of current regulatory requirements and best practices. • Conducts or supports QA review of clinical and regulatory documents, including protocols, Investigator Brochures, Clinical Study Reports, and integrated summaries, as applicable. • Supports the development and delivery of training materials and provides GCP and SOP-related training to internal stakeholders. • Collaborates with clinical teams to assess and investigate temperature excursions, deviations, and product complaints reported from clinical sites. • Participates in QA budget planning and resource forecasting activities. • Develops, monitors, and reports GCP quality metrics to support consistent quality performance across the organization. • Performs other duties and special projects as required.