Senior QA Auditor - GCP Audits

Expert OverviewIn this role, you will plan and conduct independent clinical (GCP) audits across IQVIA contracts to verify regulatory and guideline compliance. You will produce and share findings with stakeholders, and advise project teams on interpretation of regulations and policies. You will support continuous quality improvements through CAPA, RCA, and EC activities, maintain the eQMS, and lead QA initiatives. This position offers exposure to global audits, cross‑functional collaboration, and opportunities to shape compliance practices.ResponsibilitiesPlan, schedule, conduct, report and close audit activities across involved countries to assess compliance with regulations, guidelines, customer requirements, IQVIA SOPs and project guidelines.Evaluate audit findings and prepare/distribute reports to operations staff, management, and customers.Provide interpretation and consultation on regulations, guidelines, compliance status, and policies to project teams.Advise customers and monitors on audit observations and corrective action plans.Review/approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) and Effectiveness Check (EC) plans and track closure for quality events.Evaluate policies/procedures for regulatory compliance and recommend improvements.Maintain the electronic quality management system (eQMS) and support audit lifecycle.Lead/collaborate/support QA initiatives/projects and assist in training QA staff.May manage Quality Issues and present educational programs to staff on compliance procedures.Potentially perform pre‑inspection visits, host audits/inspections, and assist in regulatory facility inspections.QualificationsCertified to conduct audits in Italy in accordance with the Italian Decree of the Ministry of Health dated 15 Nov 2011.Travel 30–50% mainly in Europe.5 years experience in pharmaceutical, technical, or related area, including 3 years in Quality Assurance Audits.Experience conducting clinical trial Investigator site audits.Experience with clinical study report/data management audits preferred.Knowledge of word‑processing, spreadsheet, and database applications.Extensive knowledge of pharmaceutical R&D processes and regulatory environments.Knowledge of quality assurance processes and procedures.Strong interpersonal, problem‑solving, risk analysis and negotiation skills.Strong training capabilities and effective organization, communication, and team orientation skills.Ability to initiate tasks and work independently, manage multiple projects.BenefitsIncentive plans.Bonuses.Health benefits.Welfare benefits. #J-18808-Ljbffr