Teams at SystImmune

The HR Business Partner will support various teams by providing HR guidance on performance management, employee relations, recruiting, and organizational effectiveness, while ensuring compliance with laws and policies.

Lead establishment and continuous improvement of a GMP-compliant Quality Management System for IHC-based companion diagnostics (CDx). Oversee transition from RUO/LDT to regulated IVD CDx, design control, ISO 14971 risk management, document control, supplier quality, CAPA and change control. Serve as management representative and primary interface for FDA inspections, audits, and regulatory interactions. Build and mentor a QMS team and drive inspection readiness and regulatory submissions.

Lead CDx IHC development, managing technical strategy, team development, and regulatory compliance for oncology drug programs in a hands-on role.