Capricor Therapeutics, Inc. · 17 hours ago
Supplier Quality Management (SQM) Supervisor
San Diego, CA
Full-time
Onsite
Mid, Senior Level
$100K/yr - $118K/yr
5+ years expCapricor Therapeutics is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. The Supplier Quality Management (SQM) Supervisor plays a critical role in building and maintaining Capricor’s supplier quality program, overseeing supplier qualifications, audits, and compliance with global GMP requirements.
BiotechnologyHealthcareHealth CareMedicalTherapeutics
Responsibilities
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
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
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
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
Ensure supplier readiness for audits and regulatory inspections
Support quality systems initiatives, documentation improvements, and operational excellence projects
Perform additional duties as assigned
Qualification
Required
Bachelor's degree in Life Sciences or a related field
5–7 years of experience in supplier quality management, QA, or related functions within pharma, biotech, or medical devices
Minimum 2 years in a supervisory or leadership capacity
Strong expertise in GMP compliance, supplier auditing, and qualification processes
Working knowledge of FDA 21 CFR Part 211, EU GMP (including Annex 1), ICH guidelines, and ISO 13485
Deep understanding of supply chain processes and risk‑based quality assessments
Excellent analytical, problem‑solving, and communication skills
Highly organized with strong attention to detail
Proficiency with MS Word, Excel, Visio, Adobe Suite, and eQMS platforms
Ability to work independently and adapt within a fast‑paced environment
Preferred
Experience overseeing suppliers supporting biologics, advanced therapies, or aseptic manufacturing
Hands‑on experience with CAPA management, audit programs, and supplier remediation
Familiarity with quality systems and ERP tools (e.g., Veeva, Qt9, NetSuite, SAP)
Experience supporting regulatory inspections focused on supplier controls
Strong understanding of quality agreements, material specifications, and technical documentation
Company
Capricor Therapeutics, Inc.
Capricor Therapeutics is a publicly traded (NASDAQ: CAPR) biotechnology company with a mission to develop groundbreaking therapies that make a meaningful impact on patients’ lives.
51-200 employees
H1B Sponsorship
Capricor Therapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (2)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$329.5MKey Investors
Nippon ShinyakuNational Institutes of HealthCalifornia Institute for Regenerative Medicine
2025-12-05Post Ipo Equity· $150M
2024-10-17Post Ipo Equity· $75M
2024-09-17Post Ipo Equity· $15M
Leadership Team
AJ Bergmann
Chief Financial Officer
Recent News
2026-01-09
Company data provided by crunchbase