Overview

In 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.

Responsabilità

- Prepare 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 fondamentali

- Audits 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

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