Is the Supplier Quality Management (SQM) Supervisor role at Capricor remote?

The Supplier Quality Management (SQM) Supervisor role at Capricor is an on-site position located in San Diego, CA.

Supplier Quality Management (SQM) Supervisor

CapricorSan Diego, CA3h ago

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most.

The Supplier Quality Management (SQM) Supervisor plays a critical role in building and maintaining Capricor’s world‑class supplier quality program. This position oversees supplier qualifications, audit activities, supplier performance monitoring, and compliance with global GMP requirements across the supply chain. The role requires strong collaboration with Procurement, Manufacturing, QC, R&D, and other functional partners to ensure that externally supplied materials and services consistently meet Capricor’s quality standards. This position is ideal for detail‑oriented quality professionals with deep experience in GMP/GLP environments and a passion for continuous improvement.

Responsibilities

The responsibilities for this role include, but are not limited to:

Supplier Quality Oversight & Compliance

Lead the implementation of Capricor’s Culture of Quality across all supplier‑related operations.

Ensure adherence to FDA, EMA, and global GMP requirements across supplier quality processes.

Develop, maintain, and continuously improve supplier quality procedures, documentation, and systems.

Serve as the primary quality contact for supplier‑related regulatory inspections.

Supplier Qualification, Auditing & Performance Management

Conduct supplier qualification assessments, audits, and ongoing evaluations.

Manage and maintain supplier documentation, including quality agreements, specifications, and audit reports.

Monitor supplier performance metrics, trend results, and identify risks.

Address supplier‑related non‑conformances and lead or support CAPAs to ensure effective root cause analysis.

Drive continuous improvement initiatives strengthening supplier oversight and overall supply chain robustness.

Risk Management & Investigations

Support and contribute to supplier‑related quality risk assessments.

Perform or support investigations tied to supplier deviations, material issues, and process failures.

Conduct root cause analysis and implement appropriate corrective and preventive actions.

Cross‑Functional Collaboration

Partner with procurement, manufacturing, and R&D to ensure material quality and compliance throughout the product lifecycle.

Provide guidance on supplier requirements for new materials, process changes, and technical evaluations.

Deliver training related to supplier quality practices and GMP compliance.

Additional Responsibilities

Ensure supplier readiness for audits and regulatory inspections.

Support quality systems initiatives, documentation improvements, and operational excellence projects.

Perform additional duties as assigned.

Requirements

Bachelor’s degree in Life Sciences or a related field.

5–7 years of experience in supplier quality management, QA, or related functions within pharma, biotech, or medical devices.

Minimum 2 years in a supervisory or leadership capacity.

Strong expertise in GMP compliance, supplier auditing, and qualification processes.

Working knowledge of FDA 21 CFR Part 211, EU GMP (including Annex 1), ICH guidelines, and ISO 13485.

Deep understanding of supply chain processes and risk‑based quality assessments.

Excellent analytical, problem‑solving, and communication skills.

Highly organized with strong attention to detail.

Proficiency with MS Word, Excel, Visio, Adobe Suite, and eQMS platforms.

Ability to work independently and adapt within a fast‑paced environment.

Preferred Experience

Experience overseeing suppliers supporting biologics, advanced therapies, or aseptic manufacturing.

Hands‑on experience with CAPA management, audit programs, and supplier remediation.

Familiarity with quality systems and ERP tools (e.g., Veeva, Qt9, NetSuite, SAP).

Experience supporting regulatory inspections focused on supplier controls.

Strong understanding of quality agreements, material specifications, and technical documentation.

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.

Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address which is @capricor.com. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason.

Notice to Recruiting Agencies

Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

Supplier Quality Management (SQM) Supervisor

Responsibilities

Requirements

Preferred Experience

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