Senior QA Auditor
Pubblicato il 16-10-2026 - Iqvia in Italia
Milan, Italy
Tempo pieno
R1549435
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.
This role offers the opportunity to independently lead audit activities across a diverse portfolio of clinical research programs and collaborate with global teams to support quality, compliance, and continuous improvement initiatives.
Core Responsibilities 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 and Preventive Action (CAPA) plans.
Review, approve investigations, Root Cause Analysis (RCA), CAPA and Effectiveness Check (EC) plans and track till closure for quality events arising from Audits; and from Quality Issues, Inspections or during similar QA activities as assigned.
Perform pre-inspection visits at sites.
Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
Maintain the electronic quality management system (eQMS) and provide support in relation to the audit lifecycle.
Lead, collaborate in, or support QA initiatives and proc