h3bOverview /b /h3 pPlan 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. /p pThis 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. /p h3bCore Responsibilities /b /h3 ul liPlan, 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. /li liEvaluate audit findings and prepare and distribute reports to operations staff, management, and customers. /li liProvide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures. /li liProvide consultation to customers and monitors in interpretation of audit observations and formulation of Corrective and Preventive Action (CAPA) plans. /li liReview, 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. /li liPerform pre-inspection visits at sites. /li liEvaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements. /li liMaintain the electronic quality management system (eQMS) and provide support in relation to the audit lifecycle. /li liLead, collaborate in,



or support QA initiatives and process improvement projects. /li /ul h3bAdditional Responsibilities /b /h3 ul liDepending on business needs, the role may also include: /li liAssist in training of new Quality Assurance staff. /li liManage Quality Issues. /li liPresent educational programs and provide guidance to operational staff on compliance procedures. /li liAs assigned, host audits/inspections, ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections. /li /ul h3bRequired Qualifications /b /h3 ul libCertified to conduct audits in Italy in accordance with the Italian Decree of the Ministry of Health dated 15 November 2011. /b /li libExperience in the conduct of clinical trial Investigator Site Audits. /b /li liTravel 30-50% mainly in Europe. /li li5 years experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance Audits. /li liExtensive knowledge of pharmaceutical research and development processes, regulatory environments, and quality assurance processes and procedures. /li liStrong interpersonal skills. /li liExcellent problem solving, risk analysis and negotiation skills. /li liStrong training capabilities and ability to initiate assigned tasks and work independently. /li liEffective organization, communication and team orientation skills, with ability to manage multiple projects and establish and maintain effective working relationships with coworkers, managers and clients. /li liKnowledge of word-processing, spreadsheet, and database applications.



/li /ul h3bWhy Join IQVIA Quality Assurance /b /h3 ul liIndependently lead the full audit lifecycle, with a primary focus on Investigator Site Audits (ISAs) across a diverse portfolio of clinical research programs. /li liWork within a global quality organization supporting international clinical research programs. /li liCollaborate with experienced QA professionals and cross-functional teams across regions. /li liContribute to quality and compliance initiatives that support continuous improvement and operational excellence. /li /ul pIQVIA 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. Learn more at /p pIQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. 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. We appreciate your honesty and professionalism. /p pThe 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; location; 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. /p #J-18808-Ljbffr

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