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. Support management in promotion and assessment of compliance to regulations, guidelines and corporate policies.
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 or during similar QA activities as assigned.
Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements
Maintains the electronic quality management system (eQMS) and provides support in relation to the audit lifecycle
Lead/collaborate/support in QA initiatives/projects for quality, process improvements
Assist in training of new Quality Assurance staff




May present educational programs and provide guidance to operational staff on compliance procedures
May perform pre-inspection visits at sites, host audits/inspections; ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections, as assigned.
The right candidate must be Certified to conduct audits in Italy in accordance with the Italian Decree of the Ministry of Health dated 15 Nov 2011.
~ 5 years experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance Audits.
~ Experienced in the conduct of clinical trial Investigator site audits.
~ Experience in the conduct of clinical study report/data management clinical trial audits is preferred.
~ Knowledge of word-processing, spreadsheet, and database applications.
~ Knowledge of quality assurance processes and procedures.
~ Excellent problem solving, risk analysis and negotiation skills.
~ Strong training capabilities.
~ Ability to manage multiple projects.
~ IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.



We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. The potential base pay range for this role, when annualized, is € 47.500,00 - € 71.300,00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; and/or schedule (full or tempo parziale). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere.

📌 Senior QA Auditor - GCP Audits (Milano)
🏢 Iqvia
📍 Milano