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.
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, CSV, 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).
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. Capricor is focused on the development of biologics, primarily cell and exosome-based technologies to treat or prevent a broad range of diseases. Our lead product is a cell therapy designed to treat Duchenne muscular dystrophy (DMD), the most severe form of muscular dystrophy, which results in muscle degeneration and premature death. Capricor’s innovative exosome technology is focusing on engineering exosomes to treat or prevent diseases with high unmet medical needs. Our translational approach to product development is based on the strong research foundation provided by our academic partnerships with leading scientists at top-tier research institutions.
