14 set - Novara
Merck Sharp & Dohme (MSD)
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 reports
Communicate results to QA management and external stakeholders
Perform risk-based audits using critical-to-quality factors
Use analytics dashboards and quality metrics to identify trends and prioritize audits
Collaborate with cross-functional colleagues to drive corrective and preventive actions
Conduct GCP audits of investigator sites, study level, suppliers, and third parties
Support scheduling of audits in line with risk assessments with QAL
Escalate quality issues promptly to QAL and TA Head
Provide day-to-day QA oversight support to applicable QA functions
Travel 50% - 70%
Requisiti fondamentaliAudits Compliance
Data Analysis
Detail-Oriented
Deviation Management
Leading by Influence
Process Improvements
Quality Assurance Systems
Quality Risk Management
Technical Writing
Ownership and Accountability
Execution Excellence
Networking and Partnerships
Audits Compliance
Data Analysis
Detail-Oriented
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