Supplier Quality Specialist / Supervisor

About Capricor Therapeutics

Capricor Therapeutics is a biotechnology company dedicated to developing transformative therapies for rare diseases, with a primary focus on Duchenne muscular dystrophy (DMD). We are pioneers in cell therapy and exosome-based technology, leveraging our proprietary StealthX™ platform to engineer innovative treatments. Our team is committed to harnessing cutting-edge science and advanced technologies to meet the unmet needs of patients living with DMD and other challenging medical conditions. Join us on our journey as we push the boundaries of medical science and pave the way for a healthier future.

Position Overview

The Supplier Quality Specialist / Supervisor 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. The ideal candidate is a detail-oriented professional with extensive experience in supplier quality management and GMP / GLP environments, capable of working independently to meet project goals while ensuring regulatory compliance. 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.

Responsibilities

• Develop and Maintain Supplier Quality Program : Create, implement, and sustain a comprehensive supplier quality program to ensure consistent quality across the supply chain.
• Manage Audit Programs : Establish and oversee Capricor's external audit programs to ensure compliance with regulatory standards.
• 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.
• Generation and Management of Quality Agreements : Author, negotiate, and maintain Supplier Quality Agreements to clearly define roles, responsibilities, and quality expectations.
• 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.
• Train Employees : Provide training on relevant quality procedures to ensure consistent adherence across teams.
• Develop SOPs : Write or revise QA / QC / Supply Chain Standard Operating Procedures (SOPs) to maintain compliance.
• 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.

Requirements

Work Environment and Physical Demands

Why Capricor?

Capricor Therapeutics is an industry leader in cell and exosome therapy, pushing boundaries to create innovative treatments that raise the standard of care. Grounded in integrity and driven by science, our team is committed to making a meaningful impact through patient-centered innovation. Join us and be part of a team that's changing lives-help us shape the future of healthcare.

This role offers the ability to develop and execute vendor programs that align with the organization's vision and growth objectives. You will develop partnerships where vendor insights, expertise, and strategic perspectives are recognized and valued.

Compensation (USD)

Come Work with Us!

At Capricor, we offer a collaborative work environment that supports your professional growth. Join a passionate team committed to transforming the lives of patients and pushing the boundaries of medical science.