Capricor Therapeutics, Inc.
Supplier Quality Manager
Capricor Therapeutics, Inc., San Diego, California, United States, 92189
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). 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. Responsibilities 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 Requirements 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) Capricor Therapeutics is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive work environment and provide equal employment opportunities to all qualified applicants.
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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). 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. Responsibilities 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 Requirements 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) Capricor Therapeutics is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive work environment and provide equal employment opportunities to all qualified applicants.
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