Senior Manager, IVD Quality - San Diego California

Company: VirtualVocations
Location: San Diego, California
Posted On: 02/06/2025

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 More...

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