Qureos Mentor

Capricor Therapeutics, Inc.

<div>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&trade; 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. Reporting to Joselin Rondan, 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&rsquo;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<ul><li>
Develop and Maintain Supplier Quality Program: Create, implement, and sustain a comprehensive supplier quality program to ensure consistent quality across the supply chain.</li><li>
Manage Audit Programs: Establish and oversee Capricor&rsquo;s external audit programs to ensure compliance with regulatory standards.</li><li>
Create Supplier Scorecards: Develop and maintain scorecards to evaluate supplier performance and drive accountability.</li><li>
Ensure Audit Readiness: Maintain audit readiness and compliance with GMP and other regulatory standards.</li><li>
Conduct Supplier Qualifications and Audits: Perform supplier qualifications and risk-based audits to ensure supplier compliance and quality.</li><li>
Manage SCAR Activities: Oversee all supplier corrective action request (SCAR) processes, ensuring timely resolution of issues.</li><li>
Generation and Management of Quality Agreements: Author, negotiate, and maintain Supplier Quality Agreements to clearly define roles, responsibilities, and quality expectations.</li><li>
Collaborate on Material Specifications: Work with cross-departmental teams to develop and refine material specifications.</li><li>
Prepare Quality Metrics: Compile and present quality metrics to stakeholders to support decision-making.</li><li>
Address Quality Issues: Partner with internal teams to resolve supplier quality and audit-related challenges.</li><li>
Drive Best Practices: Contribute to the development and implementation of best practices to enhance compliance and performance.</li><li>
Perform Data Analysis: Conduct data analysis and maintain organized records, reports, and databases to support quality processes.</li><li>
Implement Continuous Improvement: Recommend and implement measures to enhance quality processes and operational efficiency.</li><li>
Train Employees: Provide training on relevant quality procedures to ensure consistent adherence across teams.</li><li>
Develop SOPs: Write or revise QA/QC/Supply Chain Standard Operating Procedures (SOPs) to maintain compliance.</li><li>
Present Data Internally: Deliver data-driven insights to support decision-making and quality initiatives.</li><li>
Work Independently: Operate with minimal supervision to achieve project goals and meet deadlines.</li><li>
Review and Approve Documents: Review and approve assigned documents to ensure accuracy and compliance.</li><li>
Perform Additional Duties: Undertake other quality-related responsibilities as assigned to support organizational objectives.</li></ul>
Requirements<ul><li>
Education: Bachelor&rsquo;s degree in a relevant Biological Science discipline required.</li><li>
Experience: 8+ 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.</li><li>
Lead Auditor Experience: Proven experience conducting audits as a lead auditor, ensuring compliance with internal and external quality standards.</li><li>
Supplier/Vendor Qualification: 8+ years of hands-on experience in qualifying suppliers and vendors, including risk assessments, capability evaluations, and ongoing performance monitoring.</li><li>
SCAR Management: Extensive experience managing Supplier Corrective Action Requests (SCARs), from initiation through closure, ensuring timely and effective resolution of quality issues.</li><li>
SOP Development: Skilled in drafting, revising, and maintaining SOPs to support quality system effectiveness and regulatory compliance.</li><li>
Supplier Quality Agreements: Demonstrated expertise in authoring, negotiating, and maintaining Supplier Quality Agreements to clearly define roles, responsibilities, and quality expectations.</li><li>
Technical Skills: Proficiency in Outlook, MS Office, and other electronic systems; experience with aseptic processing a plus.</li><li>
Communication and Teamwork: Excellent communication, time-management, and teamwork skills to collaborate effectively across departments.</li><li>
Organizational Skills: Strong organizational skills and attention to detail to manage records, reports, and databases.</li><li>
Multitasking: Ability to prioritize and manage multiple responsibilities in a fast-paced environment.</li><li>
Work Environment Adaptability: Ability to gown and work in classified areas for audits or inspections.</li><li>
Independent Work: Ability to independently perform tasks, generate reports, and escalate issues as needed.</li><li>
ASQ CQA certification preferred; candidates without current certification must demonstrate a willingness and ability to obtain certification within a specified timeframe.</li><li>
Strong team player with the ability to collaborate effectively across cross-functional departments.</li></ul>
Work Environment and Physical Demands<ul><li>
Setting: Primarily office- and laboratory-based, focusing on supplier quality management, audits, and documentation, in an office or hybrid arrangement due to limited office space.</li><li>
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.</li><li>
Travel: Occasional travel may be required for supplier audits or vendor meetings.</li></ul>
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&rsquo;s changing lives&mdash;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)<ul><li>
Salary: Commensurate with experience.</li><li>
Benefits: Comprehensive benefits package, including health insurance, retirement plans, equity awards, and opportunities for professional development.</li></ul>
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.</div>

Supplier Quality Specialist/Supervisor

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Capricor Therapeutics, Inc.

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Supplier Quality Specialist/Supervisor