🛠 Tech Stack

💼 About This Role

You'll serve as a strategic partner on cross-functional teams to ensure clinical studies meet global quality standards. You'll drive proactive quality oversight and regulatory readiness across Phase 1-3 trials. This role offers the chance to shape a culture of patient safety and data integrity.

🎯 What You'll Do

• Serve as CQA representative on Study Execution Teams
• Lead or support root cause analysis and CAPAs
• Plan and conduct audits of investigator sites, CROs, and internal processes
• Prepare audit reports and support regulatory inspections

📋 Requirements

• Bachelor's in life sciences with 10+ years industry experience or advanced degree with 7+ years
• 5+ years direct Clinical Quality Assurance or Clinical Compliance experience
• Phase 1-3 GCP audit experience and risk-based audit plans
• Experience with QMS and eTMF systems (e.g., Veeva Vault)