Supplier Quality Management (SQM) Supervisor

Capricor Therapeutics, a publicly traded (NASDAQ: CAPR) biotechnology leader, is driven by a mission to develop groundbreaking biologics—focusing on cell and exosome-based therapies—to make a meaningful impact on patients’ lives, particularly for severe conditions like Duchenne muscular dystrophy with our lead therapy, deramiocel (CAP-1002). Our innovative work extends to our StealthX™ exosome platform, harnessing cutting-edge science to address unmet medical needs through precision-engineered solutions. At the heart of everything we do is a deep commitment to patient-centered innovation, fueled by strong academic partnerships and a passion for advancing healthcare.

The Supplier Quality Management (SQM) Supervisor 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.

• Partner with Quality and cross-functional teams to implement and uphold Capricor's Culture of Quality program.
• Develop, implement, and maintain robust supplier quality management processes compliant with FDA, EMA, and other global regulatory requirements for cell therapy products.
• Conduct supplier qualification assessments, audits, and evaluations to ensure compliance with Good Manufacturing Practices (GMP) and other applicable standards.
• Oversee the development, review, and approval of supplier-related quality documents, including quality agreements, specifications, and audit reports.
• Manage supplier performance, including monitoring KPIs, addressing non-conformances, and implementing corrective and preventive actions (CAPAs).
• Collaborate with procurement, manufacturing, and R&D teams to ensure supplier materials meet stringent quality and regulatory standards.
• Support risk assessments and supplier-related investigations, conducting root cause analysis and implementing effective resolutions.
• Ensure supplier readiness for regulatory inspections and act as the primary point of contact for supplier quality during audits.
• Drive continuous improvement initiatives for supplier quality processes and systems.
• Develop and deliver training on supplier quality requirements and GMP compliance for internal teams and external partners.
• Perform additional duties as assigned.

• Minimum of 5-7 years of experience in supplier quality management, quality assurance, or a related field in the pharmaceutical, biotechnology, or medical device industry.
• At least 2 years of supervisory or leadership experience.
• Proven experience conducting supplier audits and managing supplier qualification processes with expertise in GMP requirements.
• Comprehensive knowledge of GMP, ICH guidelines, FDA regulations (e.g., 21 CFR Part 211), and international quality standards (e.g., EU GMP Annex 1).
• Strong understanding of supply chain processes, including material qualification, vendor management, and risk-based quality assessments.
• Familiarity with regulatory guidelines related to supplier quality and compliance (e.g., ISO 13485, EU MDR).
• Exceptional analytical, problem-solving, leadership, and communication skills with the ability to collaborate cross-functionally.
• Excellent organizational skills and attention to detail in managing supplier documentation and quality records.
• Proficient in MS Word, Excel, Visio, Adobe Suite, and quality management systems (e.g., eQMS).
• Results-oriented with strong initiative, independence, and the ability to thrive in a fast-paced, dynamic environment.
• Comfortable managing multiple priorities and adapting to rapidly changing demands.
• • Minimum of 5-7 years of experience in supplier quality management, quality assurance, or a related field in the pharmaceutical, biotechnology, or medical device industry.

Why Capricor?

Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that’s transforming lives with every breakthrough.

Come Work With Us!

At Capricor, you’ll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies.