Supplier Quality Associate

Overview

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 Stealth

X™ 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.

The Supplier Quality Associate is a critical role responsible for overseeing the development and maintenance of a robust supplier quality program, managing external audit programs, and ensuring compliance with Good Manufacturing Practice (GMP) standards. This position will drive supplier qualifications, conduct risk-based audits, and collaborate with cross-functional teams to maintain high-quality standards and support continuous improvement. This role will play a pivotal part in upholding Capricor’s commitment to quality and excellence in the development of innovative therapies.

The team this person will be joining develops and maintains the Supplier Quality Program, conducts supplier qualifications and audits, manages SCAR activities, generates and manages Quality Agreements, and develops SOPs.

• Develop and maintain the Supplier Quality Program:
  Create, implement, and sustain a comprehensive supplier quality program to ensure consistent quality across the supply chain
• Travel:
  Occasional travel may be required for supplier audits or vendor meetings
• Create Supplier Scorecards:
  Develop and maintain scorecards to evaluate supplier performance and drive accountability
• Ensure Audit Readiness:
  Maintain audit readiness and compliance with GMP and other regulatory standards
• Conduct Supplier Qualifications and Audits:
  Perform supplier qualifications and risk-based audits to ensure supplier compliance and quality
• Manage SCAR
  
  Activities:
  
  Oversee all supplier corrective action request (SCAR) processes, ensuring timely resolution of issues
• Collaborate on Material Specifications:
  Work with cross-departmental teams to develop and refine material specifications
• Prepare Quality Metrics:
  Compile and present quality metrics to stakeholders to support decision-making
• Address Quality Issues:
  Partner with internal teams to resolve supplier quality and audit-related challenges
• Drive Best Practices:
  Contribute to the development and implementation of best practices to enhance compliance and performance
• Perform Data Analysis:
  Conduct data analysis and maintain organized records, reports, and databases to support quality processes
• Implement Continuous Improvement:
  Recommend and implement measures to enhance quality processes and operational efficiency
• Present Data Internally:
  Deliver data-driven insights to support decision-making and quality initiatives
• Work Independently:
  Operate with minimal supervision to achieve project goals and meet deadlines
• Review and Approve Documents:
  Review and approve assigned documents to ensure accuracy and compliance
• Perform Additional Duties:
  Undertake other quality-related responsibilities as assigned to support organizational objectives

• Education:
  
  Bachelor’s degree in a relevant Biological Science discipline required
• Experience:
  
  3 years of experience in a GMP Quality Control laboratory or GMP/GLP setting required, with direct experience in Supplier Quality Management and corporate/supplier audits
• Experience conducting audits is a plus
• Supplier/Vendor
  
  Qualification:
  
  3+ years of hands-on experience in qualifying suppliers and vendors, including risk assessments, capability evaluations, and ongoing performance monitoring
• SCAR Management:
  Experience managing Supplier Corrective Action Requests (SCARs), from initiation through closure, ensuring timely and effective resolution of quality issues
• SOP Development:
  Skilled in drafting, revising, and maintaining SOPs to support quality system effectiveness and regulatory compliance
• Experience facilitating Supplier Quality Agreements is a plus
• Technical
  
  Skills:
  
  P…