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
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