Quality Compliance Associate I/II

Capricor Therapeutics • San Diego - SD3, SD

1d

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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).

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.

Benefits

• Collaborative environment that nurtures professional growth and innovation.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level