Senior Manager, IVD Quality
Job Summary
Supporting the implementation of a proactive quality strategy for In-Vitro Diagnostics (IVD) within clinical trials, the full-time remote Senior Manager, IVD Quality will manage quality oversight, collaborate with diagnostic partners, and provide regulatory expertise in precision medicine.
Key responsibilities
- Support quality oversight of IVD medical devices used in clinical trials, ensuring compliance with industry regulations
- Provide subject matter expertise on regulatory and quality oversight of IVDs, including Companion Diagnostics and Laboratory Developed Tests
- Collaborate with diagnostic partners to advance quality management strategies in response to evolving regulatory landscapes
Required qualifications
- Doctorate degree with 2 years of relevant experience, or Master's degree with 4 years, or Bachelor's degree with 6 years, or Associate's degree with 10 years, or High school diploma/GED with 12 years of experience in quality, regulatory, or Companion Diagnostics
- Experience within the pharmaceutical, biotech, or medical device industries, particularly with IVD and Companion Diagnostic devices
- Knowledge of IVD medical device development and applicable global regulations related to precision medicine
- Experience working in a quality management system role or clinical research environment with quality oversight responsibilities
- Understanding of Quality Management Systems (QMS) and compliance with GxP requirements
Complete Job Description
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