Capricor Therapeutics, Inc. · 3 hours ago
Senior Director, Quality Assurance & Quality Systems
San Diego, CA
Full-time
Onsite
Director/Executive
$210K/yr - $270K/yr
12+ years expCapricor Therapeutics is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. 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.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
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 for late-stage and commercial products (e.g., Deramiocel cell therapy production)
Ensure timely and effective resolution of quality events, deviations, CAPAs, complaints, and out-of-specification results, with appropriate escalation, root cause analysis, and management visibility
Support commercial readiness activities, including product release processes, distribution oversight, post-market quality monitoring, and pharmacovigilance integration as applicable
Collaborate closely with Clinical, Regulatory Affairs, CMC/Process Development, Manufacturing, Supply Chain, Quality Control, and Commercial teams to integrate quality principles throughout the product lifecycle and enable efficient, compliant decision-making
Provide risk-based quality guidance to support regulatory submissions, responses, and commitments while balancing compliance with operational agility in a fast-paced biotech setting
Establish, monitor, and report quality KPIs, trends, risk indicators, and compliance metrics to senior leadership and the Quality Management Review
Drive continuous improvement initiatives, including process optimizations, lessons learned from inspections/audits, and enhancements to strengthen compliance maturity, operational efficiency, and inspection outcomes
Use data analytics and trending to proactively identify, assess, and mitigate quality risks across the portfolio
Build, lead, and mentor a high-performing QA and Quality Systems organization; develop talent, succession plans, and training programs to support organizational scaling and commercialization milestones
Foster a collaborative, accountable, and inspection-ready mindset across the quality team and broader company
Qualification
Required
Bachelor's degree in Life Sciences, Engineering, Pharmacy, or a related field; advanced degree (e.g., MS, PhD) preferred
12+ years of progressive Quality Assurance experience in pharmaceutical or biotechnology environments, with significant focus on biologics, cell therapies, or advanced therapy medicinal products
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
Company
Capricor Therapeutics, Inc.
Capricor Therapeutics is a publicly traded (NASDAQ: CAPR) biotechnology company with a mission to develop groundbreaking therapies that make a meaningful impact on patients’ lives.
51-200 employees
H1B Sponsorship
Capricor Therapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (2)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$329.5MKey Investors
Nippon ShinyakuNational Institutes of HealthCalifornia Institute for Regenerative Medicine
2025-12-05Post Ipo Equity· $150M
2024-10-17Post Ipo Equity· $75M
2024-09-17Post Ipo Equity· $15M
Leadership Team
AJ Bergmann
Chief Financial Officer
Recent News
2026-01-09
Company data provided by crunchbase