Anonymous Company
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
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