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 Director, Quality Assurance & Quality Systems will lead and support quality assurance and quality systems activities for Capricor's clinical and commercial-stage biotechnology operations. The role advances the company's Quality Management System, drives inspection readiness, and ensures quality processes are scalable, compliant, and aligned with late-stage development and commercial launch. The ideal candidate brings hands-on QA and Quality Systems experience, deep knowledge of GMP and FDA requirements, and a proven ability to partner cross-functionally to build a proactive, risk-based quality culture.
Responsibilities
Quality Assurance & Quality Systems Leadership
Lead and manage the QA/QS team, ensuring alignment with company objectives and regulatory standards
Develop, implement, and maintain quality management strategies and systems to ensure compliance with GMP, FDA, ICH guidelines, and other relevant regulatory bodies
Design, establish, and continuously improve the Quality Management System (QMS), including document control, change control, training systems, and electronic quality systems (eQMS)
Quality Systems Management
Oversee the entire quality systems infrastructure, including Standard Operating Procedures (SOPs), batch records, specifications, and validation protocols
Manage document lifecycle management ensuring version control, approval workflows, and archival in compliance with regulatory requirements
Establish and maintain quality metrics dashboards and Key Performance Indicators (KPIs) for system effectiveness
Compliance & Regulatory
Establish and enforce quality assurance policies and procedures across all operational departments
Support the preparation and execution of internal audits, including regulatory inspections, to ensure compliance with regulatory requirements
Ensure timely resolution of quality-related issues, including non-conformances, deviations, and CAPA (Corrective and Preventive Actions)
Maintain inspection readiness and serve as primary QA point of contact for regulatory inspections
Cross-Functional Collaboration & Lifecycle Management
Collaborate with cross-functional teams (R&D, manufacturing, regulatory affairs, supply chain, etc.) to ensure product quality throughout the entire lifecycle
Partner with Regulatory Affairs to support CMC sections of regulatory submissions (IND, BLA, NDA)
Support technology transfer activities and new product introductions from a quality systems perspective
Continuous Improvement & Risk Management
Lead continuous improvement initiatives leveraging methodologies to enhance product quality, manufacturing processes, and operational efficiency
Provide leadership in Quality Risk Management (QRM), including identification, assessment, and mitigation of quality risks using ICH Q9 principles
Champion a culture of quality throughout the organization
Performance Management & Reporting
Prepare and present quality performance metrics, trending analysis, and reports to senior management and board of directors
Mentor and develop QA/QS staff, fostering a culture of accountability, compliance, and continuous professional growth
Requirements
Education & Experience
Bachelor's degree in Life Sciences, Engineering, or a related field (Master's degree preferred)
10+ years of progressive experience in Quality Assurance and Quality Systems, with at least 5 years in a leadership role within a regulated industry (pharmaceutical, biotechnology, or medical devices)
Direct experience in cell and gene therapy or advanced therapeutic products is highly desirable
Technical Knowledge
Strong knowledge of regulatory requirements, including FDA, GMP, ICH guidelines, ISO 13485, and 21 CFR Parts 210, 211, 600, 820, and 1271
Demonstrated expertise in Quality Management Systems (QMS) design, implementation, and maintenance
Proven experience with electronic quality systems (eQMS) platforms (e.g., Veeva, MasterControl, TrackWise, or similar)
Knowledge of Quality Risk Management methodologies (ICH Q9, FMEA, etc.)
Leadership & Management
Proven experience leading quality assurance and quality systems teams and managing cross-functional collaborations
Demonstrated ability to drive process improvements and manage complex quality systems in dynamic environments
Experience managing regulatory inspections and audit readiness programs
Skills & Competencies
Excellent problem-solving, analytical, and decision-making skills
Strong written and verbal communication skills, with the ability to interact with senior leadership, regulatory agencies, and external stakeholders
Experience in preparing and presenting reports and metrics to senior management and board members
Strong leadership and interpersonal skills, with the ability to mentor and guide teams towards excellence
Ability to work effectively in a fast-paced, entrepreneurial environment with changing priorities
Work Environment / Physical Demands
Primarily office-based with required time in GMP spaces addressing quality management and audits.
Requires prolonged periods of computer use for documentation, data analysis, and report generation related to quality processes.
May involve lifting office materials or equipment up to 10 pounds.
Ability to navigate office and GMP environments for audits and oversight.
Why Capricor?
Capricor Therapeutics is advancing cell and exosome-based therapies with a focus on serious diseases where patients and families need new treatment options. Our work is grounded in scientific rigor, collaboration, and a shared commitment to moving meaningful therapies forward. Joining Capricor means being part of a mission-driven team working at the intersection of innovation, execution, and patient impact.
Come Work With Us
At Capricor, you’ll join a collaborative environment where employees are encouraged to contribute, grow, and help build the systems, science, and operations needed to support our next stage of growth. We value people who are thoughtful, accountable, hands-on, and motivated by work that can make a real difference.
Recruiting Fraud Notice
Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by someone using an official Capricor email address ending in @capricor.com. Capricor will never ask candidates to send money, deposit a check, purchase equipment, or provide payment for any reason as part of the recruiting or onboarding process.
Notice to Recruiting Agencies
Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without express written approval from Talent Acquisition and a fully executed agreement with Capricor. Agencies that contact hiring managers directly, solicit business, or submit candidates without prior approval will not be considered for engagement. Any unsolicited submissions will become the property of Capricor Therapeutics, and no fees will be paid for candidates hired as a result of such submissions. We appreciate your cooperation and respect for this policy.