Supplier Quality Management; SQM Supervisor

Role Summary

The Supplier Quality Management (SQM) Supervisor plays a critical role in building and maintaining Capricor’s world‑class supplier quality program. This position oversees supplier qualifications, audit activities, supplier performance monitoring, and compliance with global GMP requirements across the supply chain. The role requires strong collaboration with Procurement, Manufacturing, QC, R&D, and other functional partners to ensure that externally supplied materials and services consistently meet Capricor’s quality standards.

This position is ideal for detail‑oriented quality professionals with deep experience in GMP/GLP environments and a passion for continuous improvement.

• Supplier Quality Oversight & Compliance
  • Lead the implementation of Capricor’s Culture of Quality across all supplier‑related operations
  • Ensure adherence to FDA, EMA, and global GMP requirements across supplier quality processes
  • Develop, maintain, and continuously improve supplier quality procedures, documentation, and systems
  • Serve as the primary quality contact for supplier‑related regulatory inspections
• Supplier Qualification, Auditing & Performance Management
  • Conduct supplier qualification assessments, audits, and ongoing evaluations
  • Manage and maintain supplier documentation, including quality agreements, specifications, and audit reports
  • Monitor supplier performance metrics, trend results, and identify risks
  • Address supplier‑related non‑conformances and lead or support CAPAs to ensure effective root cause analysis
  • Drive continuous improvement initiatives strengthening supplier oversight and overall supply chain robustness
• Risk Management & Investigations
  • Support and contribute to supplier‑related quality risk assessments
  • Perform or support investigations tied to supplier deviations, material issues, and process failures
  • Conduct root cause analysis and implement appropriate corrective and preventive actions
• Cross‑Functional Collaboration
  • Partner with procurement, manufacturing, and R&D to ensure material quality and compliance throughout the product lifecycle
  • Provide guidance on supplier requirements for new materials, process changes, and technical evaluations
  • Deliver training related to supplier quality practices and GMP compliance
• Additional Responsibilities
  • Ensure supplier readiness for audits and regulatory inspections
  • Support quality systems initiatives, documentation improvements, and operational excellence projects
  • Perform additional duties as assigned

• Required: 5–7 years of experience in supplier quality management, QA, or related functions within pharma, biotech, or medical devices
• Required: Minimum 2 years in a supervisory or leadership capacity
• Required: Strong expertise in GMP compliance, supplier auditing, and qualification processes
• Required: Working knowledge of FDA 21 CFR Part 211, EU GMP (including Annex
  1), ICH guidelines, and ISO 13485
• Required: Deep understanding of supply chain processes and risk‐based quality assessments
• Required: Excellent analytical, problem‑solving, and communication skills
• Required: Highly organized with strong attention to detail
• Required: Proficiency with MS Word, Excel, Visio, Adobe Suite, and eQMS platforms
• Required: Ability to work independently and adapt within a fast‑paced environment
• Preferred: Experience overseeing suppliers supporting biologics, advanced therapies, or aseptic manufacturing
• Preferred: Hands‑on experience with CAPA management, audit programs, and supplier remediation
• Preferred: Familiarity with quality systems and ERP tools (e.g., Veeva, Qt9, Net Suite, SAP)
• Preferred: Experience supporting regulatory inspections focused on supplier controls
• Preferred: Strong understanding of quality agreements, material specifications, and technical documentation

• Bachelor’s degree in Life Sciences or a related field

• GMP compliance, supplier auditing, and qualification processes
• CAPA management, audit programs, and supplier remediation
• Cross‑functional collaboration
• Analytical, problem‑solving, and communication
• Attention to detail and strong organizational skills
• Proficiency with MS Word, Excel, Visio, Adobe Suite, and eQMS platforms