Teams at Jade Biosciences, Inc.

Lead development, implementation, and continual improvement of a phase-appropriate GxP Quality Management System. Oversee QMS processes (Document/Training/Change Control/Deviation/CAPA/Risk/GxP computer systems), drive inspection readiness, manage electronic systems and vendors, set quality metrics, coach teams, and support regulatory interactions across Development, Clinical, and CMC functions.

Lead GMP Quality Assurance activities for outsourced manufacturing and supply operations across clinical and commercial stages. Oversee CDMOs, review and approve quality records, manage quality agreements, drive risk management, support regulatory submissions and inspections, and coordinate cross-functional QA documentation, batch release, and issue resolution to ensure compliance with cGMP and regulatory requirements.

The Senior Director, Clinical Operations is responsible for overseeing clinical programs, managing CROs, and providing strategic recommendations to leadership, while ensuring clinical operations meet regulatory standards and organizational goals.