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.Quality Assurance & Quality Systems LeadershipLead and manage the QA/QS team, ensuring alignment with company objectives and regulatory standardsDevelop, implement, and maintain quality management strategies and systems to ensure compliance with GMP, FDA, ICH guidelines, and other relevant regulatory bodiesDesign, establish, and continuously improve the Quality Management System (QMS), including document control, change control, training systems, and electronic quality systems (eQMS)Quality Systems ManagementOversee the entire quality systems infrastructure, including Standard Operating Procedures (SOPs), batch records, specifications, and validation protocolsManage document lifecycle management ensuring version control, approval workflows, and archival in compliance with regulatory requirementsEstablish and maintain quality metrics dashboards and Key Performance Indicators (KPIs) for system effectivenessCompliance & RegulatoryEstablish and enforce quality assurance policies and procedures across all operational departmentsSupport the preparation and execution of internal audits, including regulatory inspections, to ensure compliance with regulatory requirementsEnsure 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 inspectionsCross‑Functional Collaboration & Lifecycle ManagementCollaborate with cross‑functional teams (R & D, manufacturing, regulatory affairs, supply chain, etc.) to ensure product quality throughout the entire lifecyclePartner 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 perspectiveContinuous Improvement & Risk ManagementLead continuous improvement initiatives leveraging methodologies to enhance product quality, manufacturing processes, and operational efficiencyProvide leadership in Quality Risk Management (QRM), including identification, assessment, and mitigation of quality risks using ICH Q9 principlesChampion a culture of quality throughout the organizationPerformance Management & ReportingPrepare and present quality performance metrics, trending analysis, and reports to senior management and board of directorsMentor and develop QA/QS staff, fostering a culture of accountability, compliance, and continuous professional growthEducation & ExperienceBachelor'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 desirableTechnical KnowledgeStrong knowledge of regulatory requirements, including FDA, GMP, ICH guidelines, ISO 13485, and 21 CFR Parts 210, 211, 600, 820, and 1271Demonstrated expertise in Quality Management Systems (QMS) design, implementation, and maintenanceProven 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 & ManagementProven experience leading quality assurance and quality systems teams and managing cross‑functional collaborationsDemonstrated ability to drive process improvements and manage complex quality systems in dynamic environmentsExperience managing regulatory inspections and audit readiness programsSkills & CompetenciesExcellent problem‑solving, analytical, and decision‑making skillsStrong written and verbal communication skills, with the ability to interact with senior leadership, regulatory agencies, and external stakeholdersExperience in preparing and presenting reports and metrics to senior management and board membersStrong leadership and interpersonal skills, with the ability to mentor and guide teams towards excellenceAbility to work effectively in a fast‑paced, entrepreneurial environment with changing prioritiesWorking ConditionsPrimarily 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.#J-18808-Ljbffr