Quality Compliance Associate I/II

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. Responsibilities Plan, execute, and report on internal audits of GxP processes (e.g., GMP manufacturing, QC, validation, laboratories, supply chain). Lead or support supplier/vendor audits and monitor ongoing supplier performance. Prepare detailed audit agendas, checklists, and sampling strategies aligned with risk and compliance priorities. Document findings clearly; issue audit reports with classifications, evidence, and actionable recommendations. Track and verify effectiveness of CAPAs (Corrective and Preventive Actions) and drive timely closure. Support inspection readiness activities and host/liaise during regulatory inspections (e.g., FDA, EMA, MHRA). Perform gap assessments against current regulations and industry standards; propose reasonable improvements. Collaborate with QA/QC, Manufacturing, Regulatory, Supply Chain, and IT to strengthen quality systems. Maintain audit schedules, metrics, and dashboards; communicate status to stakeholders and management. Contribute to policy/SOP development, training, and continuous improvement initiatives. Qualifications Bachelor's degree in a scientific or technical field (e.g., Chemistry, Biology, Engineering) or equivalent experience. 1-2 years of auditing experience within biopharma, biotech, medical devices, or related regulated industry. Working knowledge of FDA 21 CFR Parts 210/211, ICH Q-series, EU GMP, and GDP principles. Experience performing audits against quality system elements (Deviation, CAPA, Change Control, Training, Document Control). Strong technical writing skills and attention to detail; able to produce clear, evidence-based audit reports. Proficiency with risk-based auditing, root cause analysis, and CAPA effectiveness verification. Excellent communication and stakeholder management skills; comfortable engaging at all levels. Certified Quality Auditor (CQA) – ASQ , or equivalent certification. Experience auditing CMOs/CDMOs and complex supply chains. Background with data integrity, CS CV, Annex 11, and Part 11 assessments. Exposure to biologics, cell & gene therapy, aseptic processing, or sterile manufacturing. Knowledge of ISO 9001/13485, 21 CFR 210/211, and pharmacovigilance quality systems (as applicable). #J-18808-Ljbffr Capricor