Job Details

Lead in the development and implementation of quality strategy and associated capabilities to support the CDS objectives Manage quality review of clinical trial documents, workflows, and outputs within the CDS organization to ensure clinical trials are conducted in compliance with Gilead procedures, GCP and applicable global regulations Analyze trends to identify process gaps, improvement opportunities and areas requiring corrective/preventive actions Lead new quality focused initiatives focused on new learnings, findings, and observations to continuously improve CDS quality practices and methods Work closely with Gilead CDS study team to provide expert advice on compliance issues and risk mitigation actions Collaborate with the audit, inspection and CAPA management team within Gilead R&D Quality on internal audits, regulatory agency inspections, risk assessment, deviations and CAPA activities Liaison and coordinate with business experts and stakeholders to support resolution of audit ...Clinical, Data Science, Compliance, Director, Associate, Science, Technology