Senior QA Auditor - GCP Audits

Job Title: Senior QA Auditor - GCP Audits Job Location: Parsippany, New Jersey, United States of America Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Overview: Plan and conduct independent clinical (GCP) audits to assess compliance with regulations, guidelines, and operating procedures. Prepare and distribute reports of findings to supervisor, operations staff, management, and customers. Provide consultation in interpretation of regulations, guidelines, policies, and procedures. Support management in promotion and assessment of compliance to regulations, guidelines and corporate policies. Essential Functions : Plan, schedule, conduct, report and close audit activities in any of the countries involved with IQVIA contracts to assess compliance with applicable regulations/guidelines, customer requirements, IQVIA SOPs and project specific guidelines/instructions Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures Provide consultation to customers and monitors in interpretation of audit observations and formulation of corrective action plans Review, approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) and Effectiveness Check (EC) plans and track till closure for quality events arising from Audits; and from Quality Issues, Inspections