OverviewIn this role you will support QA for clinical trials, ensuring participant safety and data integrity while complying with global regulations. You will conduct and report on audits, work with cross-functional teams to close QA observations, and apply risk-based approaches to audit planning. You will leverage data analytics to detect trends and drive continuous quality improvement. The role offers cross-site collaboration, opportunities to influence quality culture,



and significant travel to sites.ResponsabilitàPrepare and conduct QA audits and generate audit reportsCommunicate results to QA management and external stakeholdersPerform risk-based audits using critical-to-quality factorsUse analytics dashboards and quality metrics to identify trends and prioritize auditsCollaborate with cross-functional colleagues to drive corrective and preventive actionsConduct GCP audits of investigator sites, study level, suppliers, and third partiesSupport scheduling of audits in line with risk assessments with QALEscalate quality issues promptly to QAL and TA HeadProvide day-to-day QA oversight support to applicable QA functionsTravel 50% - 70%Requisiti fondamentaliAudits ComplianceData AnalysisDetail-OrientedDeviation ManagementLeading by InfluenceProcess ImprovementsQuality Assurance SystemsQuality Risk ManagementTechnical WritingOwnership and AccountabilityExecution ExcellenceNetworking and PartnershipsAudits ComplianceData AnalysisDetail-Oriented

📌 Sr. Specialist, Quality Assurance (Volpiano)
🏢 Merck Sharp & Dohme (MSD)
📍 Volpiano