Senior Director, Quality Assurance & Quality Systems

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most.

The Senior Director, Quality Assurance & Quality Systems provides strategic and operational leadership for all quality activities supporting Capricor’s clinical-stage and advancing commercial-stage organization. This role has full accountability for the design, execution, and continuous improvement of the Quality Management System (QMS) to ensure sustained regulatory compliance, inspection readiness, and robust quality oversight across development, manufacturing (including cell therapy production), and potential commercialization of Deramiocel and StealthX™-based programs.

The Senior Director partners closely with executive leadership, Regulatory Affairs, CMC, Clinical, Manufacturing, and other cross-functional teams to enable late-stage development, BLA submissions and responses (including addressing any quality-related aspects of the Deramiocel pathway), commercial readiness, and scalable growth while embedding a proactive, risk-based quality culture across the enterprise.