Senior Director, Quality Assurance & Quality Systems

Capricor Therapeutics is a biotechnology company seeking a Senior Director, Quality Assurance & Quality Systems to provide strategic and operational leadership for all quality activities. The 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, and potential commercialization of Deramiocel and StealthXTM-based programs.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, Pharmacy, or a related field
• 12+ years of progressive Quality Assurance experience in pharmaceutical or biotechnology environments
• 7+ years of senior leadership experience with direct ownership and oversight of enterprise Quality Management Systems in a growing organization
• Hands-on experience supporting late-stage clinical programs, BLA submissions, pre-approval inspections (PAIs), and commercial readiness/launch activities for regenerative medicine or biologics products
• Deep knowledge of FDA regulations (including 21 CFR Parts 210/211, 820, biologics-specific guidance), GMP, ICH guidelines (Q8-Q12, etc.), and global standards relevant to cell and exosome therapies
• Demonstrated success leading regulatory inspections (PAIs, routine GMP inspections), responding to findings, and maintaining inspection readiness in dynamic settings
• Proven ability to scale QMS and quality organizations in a rapidly growing biotech company preparing for commercialization
• Strong executive presence with the ability to influence, collaborate with, and advise cross-functional teams and senior leadership
• Excellent communication, problem-solving, decision-making, and strategic thinking skills

Benefits

• Competitive salary ($210,000 - $270,000 a year)
• Comprehensive benefits package (not specified)