Job Description
Job DescriptionAbout 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 Manager is a critical role responsible for overseeing the development and maintenance of a robust supplier quality program, managing internal and external audit programs, and ensuring compliance with Good Manufacturing Practice (GMP) standards. Reporting to the Quality Assurance leadership, 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.
Responsibilities
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Develop and Maintain Supplier Quality Program: Create, implement, and sustain a comprehensive supplier quality program to ensure consistent quality across the supply chain.
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Manage Audit Programs: Establish and oversee Capricor’s internal and external audit programs to ensure compliance with regulatory standards.
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Create Supplier Scorecards: Develop and maintain scorecards to evaluate supplier performance and drive accountability.
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Ensure Audit Readiness: Maintain audit readiness and compliance with GMP and other regulatory standards.
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Conduct Supplier Qualifications and Audits: Perform supplier qualifications and risk-based audits to ensure supplier compliance and quality.
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Manage SCAR Activities: Oversee all supplier corrective action request (SCAR) processes, ensuring timely resolution of issues.
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Perform Internal Audits: Conduct internal audits to verify adherence to quality standards and identify areas for improvement.
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Collaborate on Material Specifications: Work with cross-departmental teams to develop and refine material specifications.
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Prepare Quality Metrics: Compile and present quality metrics to stakeholders to support decision-making.
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Address Quality Issues: Partner with internal teams to resolve supplier quality and audit-related challenges.
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Drive Best Practices: Contribute to the development and implementation of best practices to enhance compliance and performance.
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Perform Data Analysis: Conduct data analysis and maintain organized records, reports, and databases to support quality processes.
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Implement Continuous Improvement: Recommend and implement measures to enhance quality processes and operational efficiency.
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Train Employees: Provide training on relevant quality procedures to ensure consistent adherence across teams.
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Develop SOPs: Write or revise QA/QC/Supply Chain Standard Operating Procedures (SOPs) to maintain compliance.
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Present Data Internally: Deliver data-driven insights to support decision-making and quality initiatives.
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Work Independently: Operate with minimal supervision to achieve project goals and meet deadlines.
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Review and Approve Documents: Review and approve assigned documents to ensure accuracy and compliance.
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Perform Additional Duties: Undertake other quality-related responsibilities as assigned to support organizational objectives.
Requirements
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Education: Bachelor’s degree in a relevant Biological Science discipline required.
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Experience: 5-7 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.
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Technical Skills: Proficiency in Outlook, MS Office, and other electronic systems; experience with aseptic processing a plus.
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Communication and Teamwork: Excellent communication, time-management, and teamwork skills to collaborate effectively across departments.
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Organizational Skills: Strong organizational skills and attention to detail to manage records, reports, and databases.
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Multitasking: Ability to prioritize and manage multiple responsibilities in a fast-paced environment.
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Work Environment Adaptability: Ability to gown and work in classified areas for audits or inspections.
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Independent Work: Ability to independently perform tasks, generate reports, and escalate issues as needed.
Work Environment and Physical Demands
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Setting: Primarily office- and laboratory-based, focusing on supplier quality management, audits, and documentation.
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Physical Requirements: Requires gowning and working in classified areas; involves prolonged periods of computer use for data analysis, report generation, and SOP development; occasional lifting of office materials or equipment up to 20 pounds.
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Travel: Occasional travel may be required for supplier audits or vendor meetings.
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.
Compensation (USD)
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Salary Range: Competitive, commensurate with experience.
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Benefits: Comprehensive benefits package, including health insurance, retirement plans, equity awards, and opportunities for professional development.
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.