Post-Marketing Quality Compliance Associate 2

Role Summary

Join Capricor Therapeutics’ Quality Compliance department to conduct internal and external audits ensuring biopharma operations comply with applicable regulations, standards, and company procedures. The role requires hands-on GMP/GxP auditing experience within the life sciences industry, with cross-functional collaboration to drive continuous improvement and a strong culture of compliance. The position may involve activities related to post-marketing safety and surveillance as needed.

Responsibilities

• Internal Audits: Plan, conduct, and report risk-based GxP audits across manufacturing, QC, labs, validation, and supply chain
• Supplier Audits: Lead and support vendor audits and monitor ongoing supplier performance, as needed
• Audit Execution: Develop audit agendas, checklists, and sampling strategies aligned with regulatory expectations
• Reporting & CAPA: Issue clear audit reports, classify findings, and track CAPA effectiveness to closure
• Inspection Readiness: Support regulatory inspection readiness
• Gap Assessments: Assess compliance against regulations and industry standards and recommend improvements
• Cross-Functional Partnership: Collaborate with QA/QC, Manufacturing, Regulatory, Supply Chain, and IT to strengthen quality systems
• Metrics & Communication: Maintain audit schedules, dashboards, and communicate status and trends to management
• Quality Improvement: Support SOP development, training, and continuous improvement initiatives
• Additional Support: Willing to support activities related to post-marketing safety and surveillance and additional responsibilities as needed

Qualifications

• Required: Bachelor’s degree in a scientific or technical field (e.g., Chemistry, Biology, Engineering) or equivalent experience
• Required: 2–5 years of auditing experience within biopharma, biotech, medical devices, or related regulated industry, including audits against quality system elements (Deviation, CAPA, Change Control, Training, Document Control)
• Required: Working knowledge of FDA 21 CFR Parts 210/211, ICH Q-series, EU GMP, and GxP principles
• Required: Strong writing skills and attention to detail; able to produce clear, evidence-based audit reports
• Required: Proficiency with risk-based auditing, root cause analysis, and CAPA effectiveness verification
• Required: Excellent communication and stakeholder management skills; comfortable engaging at all levels
• Preferred: Certified Quality Auditor (CQA) – ASQ, or equivalent certification; candidates without certification must demonstrate the ability and willingness to obtain it within a defined timeframe
• Preferred: Experience auditing CMOs/CDMOs and complex supply chains
• Preferred: Background with data integrity, CSV, Annex 11, and Part 11 assessments
• Preferred: Exposure to biologics, cell & gene therapy, aseptic processing, or sterile manufacturing
• Preferred: Knowledge of ISO 9001/13485 and quality systems related to post-marketing safety and surveillance (as applicable)

Education

• Bachelor’s degree in a scientific or technical field (e.g., Chemistry, Biology, Engineering) or equivalent experience

Skills

• Integrity and objectivity in evidence gathering and reporting
• Risk-based thinking and prioritization
• Analytical problem-solving and pragmatic recommendations
• Collaboration across functions and suppliers
• Time management, organization, and follow-through