Supplier Quality Management (SQM) Manager

Capricor Therapeutics•San Diego - SD3, SD

4d•Hybrid

About The Position

Capricor Therapeutics is seeking a Supplier Quality Management (SQM) Manager to oversee the development and maintenance of a robust supplier quality program. This role is critical for managing external audit programs, ensuring compliance with Good Manufacturing Practice (GMP) standards, and driving supplier qualifications. The SQM Manager will conduct risk-based audits, collaborate with cross-functional teams to maintain high-quality standards, and support continuous improvement in the development of transformative cell and exosome-based therapies for rare diseases. 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 position will play a pivotal part in upholding Capricor’s commitment to quality and excellence.

Requirements

Bachelor’s degree in a relevant Biological Science discipline required.
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.
Proven experience conducting audits as a lead auditor, ensuring compliance with internal and external quality standards.
7+ years of hands-on experience in qualifying suppliers and vendors, including risk assessments, capability evaluations, and ongoing performance monitoring.
Extensive experience managing Supplier Corrective Action Requests (SCARs), from initiation through closure, ensuring timely and effective resolution of quality issues.
Skilled in drafting, revising, and maintaining SOPs to support quality system effectiveness and regulatory compliance.
Demonstrated expertise in authoring, negotiating, and maintaining Supplier Quality Agreements to clearly define roles, responsibilities, and quality expectations.

Nice To Haves

Proficiency in Outlook, MS Office, and other electronic systems; experience with aseptic processing a plus.
Excellent communication, time-management, and teamwork skills to collaborate effectively across departments.
Strong organizational skills and attention to detail to manage records, reports, and databases.
Ability to prioritize and manage multiple responsibilities in a fast-paced environment.
Ability to gown and work in classified areas for audits or inspections.
Ability to independently perform tasks, generate reports, and escalate issues as needed.
ASQ CQA certification preferred; candidates without current certification must demonstrate a willingness and ability to obtain certification within a specified timeframe.
Strong team player with the ability to collaborate effectively across cross-functional departments.

Responsibilities

Create, implement, and sustain a comprehensive supplier quality program to ensure consistent quality across the supply chain.
Establish and oversee Capricor’s external audit programs to ensure compliance with regulatory standards.
Develop and maintain scorecards to evaluate supplier performance and drive accountability.
Maintain audit readiness and compliance with GMP and other regulatory standards.
Perform supplier qualifications and risk-based audits to ensure supplier compliance and quality.
Oversee all supplier corrective action request (SCAR) processes, ensuring timely resolution of issues.
Author, negotiate, and maintain Supplier Quality Agreements to clearly define roles, responsibilities, and quality expectations.
Work with cross-departmental teams to develop and refine material specifications.
Compile and present quality metrics to stakeholders to support decision-making.
Partner with internal teams to resolve supplier quality and audit-related challenges.
Contribute to the development and implementation of best practices to enhance compliance and performance.
Conduct data analysis and maintain organized records, reports, and databases to support quality processes.
Recommend and implement measures to enhance quality processes and operational efficiency.
Provide training on relevant quality procedures to ensure consistent adherence across teams.
Write or revise QA/QC/Supply Chain Standard Operating Procedures (SOPs) to maintain compliance.
Deliver data-driven insights to support decision-making and quality initiatives.
Operate with minimal supervision to achieve project goals and meet deadlines.
Review and approve assigned documents to ensure accuracy and compliance.
Undertake other quality-related responsibilities as assigned to support organizational objectives.