Associate Director, Clinical Data Science Compliance Oversight at Gilead Sciences

Lead the development and implementation of quality strategy and capabilities for Clinical Data Science (CDS) objectives. Manage the quality review of clinical trial documents, workflows, and outputs to ensure compliance with Gilead procedures, GCP, and global regulations. Analyze trends to identify process gaps, improvement opportunities, and areas requiring corrective/preventive actions. Lead new quality initiatives to continuously improve CDS quality practices. Provide expert advice on compliance issues and risk mitigation actions to CDS study teams. Collaborate with the audit, inspection, and CAPA management team on internal audits, regulatory inspections, risk assessment, deviations, and CAPA activities. Coordinate with business experts and stakeholders to support the resolution of audit outcomes. Serve as a Change Champion for Gilead QMS-related communications to the CDS organization. Analyze new regulations and policies, particularly GCP, and partner with stakeholders to update internal documentation and practices. Foster a commitment to quality within the CDS organization and with CDS-related service providers.