Director, Quality Assurance & Quality Systems

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. This 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.

• 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)

• 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

• 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

• 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

• 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

• 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

• 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

• 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, Master Control, Track Wise, or similar)
• Knowledge of Quality Risk Management methodologies (ICH Q9, FMEA, etc.)

• Proven experience leading quality assurance and quality systems teams and managing cross‑functional collaborations
• Demonstrated ability to drive process improvements and manage complex…