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Capricor Therapeutics

Posted 10 days ago

Open

Quality Compliance Associate I/II

San DiegoOn-site

AI Summary

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.

About this role

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.

Key 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.

Minimum 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.

Preferred Qualifications

  • 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).

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