Manager IVD CDx Quality

Job Summary

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

Key Responsibilities:

• Support quality oversight of In-Vitro Diagnostic (IVD) medical devices used within clinical trials
• Provide subject matter expertise on IVD development and operation in precision medicine
• Collaborate with diagnostic partners to ensure quality oversight of IVDs used in drug clinical trials

Required Qualifications:

• Doctorate, Master’s, Bachelor’s, Associate’s degree, or High school diploma/GED with relevant experience
• Experience in quality, regulatory, or Companion Diagnostic field
• Experience managing people or leading teams/projects
• Understanding of IVD regulations and Global Regulations
• Experience with Quality Management Systems and compliance to GxP requirements