Quality Compliance Associate I/II

About the role

Capricor Therapeutics is seeking a Quality Compliance Associate to join its Quality Compliance department. The role focuses on conducting internal and external audits to ensure biopharma operations meet regulatory, standard, and company requirements.

Key responsibilities

• Plan, execute, and report internal GxP audits across manufacturing, QC, validation, labs, and supply chain.
• Lead or support supplier/vendor audits and monitor supplier performance.
• Prepare audit agendas, checklists, and sampling strategies aligned with risk priorities.
• Document findings, issue audit reports with classifications, evidence, and actionable recommendations.
• Track CAPA effectiveness and drive timely closure.
• Support inspection readiness and liaise during FDA, EMA, or MHRA inspections.
• Perform gap assessments against current regulations and propose 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.
• Contribute to policy/SOP development, training, and continuous‑improvement initiatives.

Required profile

• Bachelor's degree in a scientific or technical field or equivalent experience.
• 1‑2 years of auditing experience in 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 auditing quality‑system elements such as Deviation, CAPA, Change Control, Training, and Document Control.
• Strong technical writing and attention to detail.
• Excellent communication and stakeholder‑management skills.

Required skills

• FDA 21 CFR Parts 210/211
• ICH Q‑series
• EU GMP
• GDP principles
• GMP/GxP auditing
• CAPA management
• Risk‑based auditing
• Root cause analysis
• Technical writing