Capricor Therapeutics

Capricor Therapeutics

Quality Compliance Associate I/II

San Diego - SD3 · Mid

Sponsorship not specified$70k-$82kDetected 27 days ago
ExpressStakeholder ManagementAuditingSupply ChainRecruitingGMPFDA RegulatoryCRISPRPharmacovigilanceMedical DevicesCommunicationCollaborationWritingGxP

About the role

  • Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases.
  • 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

  • Lead or support supplier/vendor audits and monitor ongoing supplier performance.
  • Document findings clearly
  • 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
  • Collaborate with QA/QC, Manufacturing, Regulatory, Supply Chain, and IT to strengthen quality systems.
  • Maintain audit schedules, metrics, and dashboards
  • Document findings clearly; issue audit reports with classifications, evidence, and actionable recommendations.
  • Perform gap assessments against current regulations and industry standards; propose reasonable improvements.
  • Maintain audit schedules, metrics, and dashboards; communicate status to stakeholders and management.

Requirements

  • Bachelor's degree in a scientific or technical field (e.g., Chemistry, Biology, Engineering) or equivalent experience.
  • Working knowledge of FDA 21 CFR Parts 210/211, ICH Q-series, EU GMP, and GDP principles.
  • Proficiency with risk-based auditing, root cause analysis, and CAPA effectiveness verification.

Nice to have

  • Certified Quality Auditor (CQA) - ASQ, or equivalent certification.
  • Experience auditing CMOs/CDMOs and complex supply chains.
  • Background with data integrity, CS V, 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 advancing cell and exosome-based therapies with a focus on serious diseases where patients and families need new treatment options.
  • Our work is grounded in scientific rigor, collaboration, and a shared commitment to moving meaningful therapies forward.
  • We value people who are thoughtful, accountable, hands-on, and motivated by work that can make a real difference.

Compensation

  • $70k-$82k

Company info

  • We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology.
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This listing is sourced directly from Capricor Therapeutics's careers page and normalized into a canonical job model.