SystImmune is seeking a Director, Head of Quality Management System (QMS) to lead the QMS for IHC-based Companion Diagnostics across development, validation, manufacturing, regulatory submission, and post-market lifecycle.
The role focuses on GMP/QSR compliance, ISO 13485 alignment, and 21 CFR 820, with responsibility for RUO/LDT → regulated IVD CDx transitions and regulatory success.
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