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 Stealth

X™ 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 Stealth

X™-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.

• Provide strategic vision and operational direction for the Quality organization to ensure all programs meet the highest standards of safety, efficacy, and regulatory compliance.

• Define and execute the enterprise quality strategy aligned with late-stage clinical development, BLA/regulatory submissions, potential commercial launch, and post-approval lifecycle management for cell and exosome-based therapies.
• Serve as the senior Quality leader and strategic advisor to executive and operations management on compliance matters, inspection readiness, quality risk management, and GxP expectations in a biotech environment.
• Establish and reinforce a strong quality culture emphasizing accountability, data integrity, continuous improvement, and risk-based decision-making throughout the organization.

• Own and continuously enhance the enterprise QMS to support clinical, manufacturing, and commercial operations, including Document Control and Change Management, Deviations/Investigations/CAPA, Training and Qualification, Data Integrity and Records Management, and other core quality processes.
• Ensure quality systems are phase-appropriate, scalable, efficient, and fully aligned with FDA GMP regulations (21 CFR Parts 210/211, 820, and biologics-specific guidance), ICH guidelines, ISO standards, and global expectations for advanced therapies.
• Lead QMS readiness and optimization for commercialization, pre-approval inspections (PAIs), post-approval commitments, and lifecycle management of Deramiocel and future products.

• Ensure ongoing compliance with FDA, GMP, and applicable global regulations for clinical trials, manufacturing, and potential commercial activities, including cell therapy and exosome platforms.
• Lead preparation for, management of, and response to regulatory inspections (including PAIs), partner audits, and health authority interactions; act as the primary Quality representative during agency engagements and inspections.
• Support quality-related aspects of regulatory submissions, responses to information requests, and commitments (e.g., contributing to BLA updates addressing any quality/CMC items).

• Provide comprehensive quality oversight for clinical quality assurance, including GCP compliance and support for ongoing trials such as HOPE-3 extensions or related activities.
• Oversee quality support for manufacturing, testing, process validation, technology transfer, comparability studies, and supply chain activities…