Senior Manager, IVD Quality

Job Summary

A company is looking for a Senior Manager, In-Vitro Diagnostics/ Companion Diagnostics/ Precision Medicine Quality.

Key Responsibilities

• Support quality oversight of IVD medical devices in clinical trials
• Provide expertise on regulatory and quality oversight of IVDs and CDx
• Collaborate with diagnostic partners to ensure compliance with industry standards

Required Qualifications

• Doctorate degree with 2 years of relevant experience, or equivalent education and experience
• Experience in the pharmaceutical/biotech, medical device, or biomarker industry
• Knowledge of IVD medical device development and global regulations
• Experience in quality management systems or clinical research quality oversight
• Understanding of GxP requirements and third-party vendor oversight