Product Quality Specialist
About The Position
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 Product Quality Specialist supports Capricor's cell therapy programs by assisting in the implementation of cGMP requirements, regulatory expectations, and industry best practices. This role contributes to product quality activities that enable clinical and commercial production, including documentation review, investigation support, data trending, and coordination of quality processes. The position requires effective cross-functional collaboration across sites, program teams, and partner functions to help ensure products consistently meet established quality standards and organizational objectives.
Requirements
- Bachelor's degree in Life Sciences, Biotechnology, or a related field.
- 4+ years of experience in manufacturing, process engineering, quality assurance or quality control, with a focus on biologics, cell therapy / advanced therapies, or similar fields within the biotech or pharmaceutical industry.
- Strong knowledge of cGMP regulations, FDA/EMA guidelines, and ICH Q-series guidelines applicable to cell-based and biologic products.
- Strong working knowledge of ALCOA+ and data integrity expectations.
- Excellent written and verbal communication skills with a strong ability to present information clearly and logically.
- Effective teamwork skills, ability to foster collaboration, and work effectively in a fast-paced, cross-functional environment.
- Exhibits strong attention to detail and adherence to established QA procedures.
Nice To Haves
- Experience with aseptic processing, sterility assurance, and quality control testing for cell therapies.
- Experience supporting product quality in clinical and commercial settings, including batch release, deviation management, and regulatory inspections.
- Experience supporting stability programs or specification-related documentation.
- Hands-on experience with deviation management, CAPAs, and change controls, including drafting investigation summaries.
- Familiarity with regulatory requirements for autologous and allogeneic cell-based / advanced therapies.
- Experience reviewing or supporting trending of product quality data.
- Experience with QMS systems (Qt9, Veeva, etc.) and ERP platforms (NetSuite, SAP, etc.).
Responsibilities
- Quality Management and Oversight: Ensure cGMP compliance throughout all stages of product development, including clinical and commercial production.
- Support investigations and provide quality oversight for deviations, CAPAs, OOS/OOT/invalid results, and change controls; ensure timely and effective root cause analysis.
- Review product-related investigations and provide clear, well-supported assessments of product impact.
- Partner with cross-functional teams to ensure quality processes, documentation, and decisions align with regulatory and company objectives.
- Product Lifecycle & Disposition Support: Act as the product quality steward, providing oversight of product quality trends, specifications, stability, and critical quality attributes (CQAs).
- Participate as a non-voting representative atMaterial Review Board (MRB) to provideproduct impact assessments and disposition recommendations.
- Analyze product quality data to detect trends, variability, or emerging risks; recommend corrective or preventive measures as needed.
- Contribute to comparability assessments (per ICH Q5E) for manufacturing or process changes impacting product quality.
- Specifications, Methods, and Stability Oversee and maintain the lifecycle of product specifications, including justification, and revisions.
- Collaborate closely with QC and analytical development teams to ensure sampling plans, test methods, and acceptance criteria remain appropriate and scientifically justified.
- Provide Quality support for QC investigations, including OOS/OOT assessments, invalid results, and method performance trends.
- Oversee execution and trending of stability studies; review protocols, reports, and data to support shelf-life determinations and regulatory filings.
- Quality Risk Management Contribute to product-specific quality risk assessments (ICH Q9) covering CQAs, manufacturing controls, process risks, and testing risks.
- Ensure product control strategies remain current, robust, and aligned with evolving process understanding.
- Support stage-appropriate process validation and continued process verification activities, as applicable.
- Supplier and External Partner Management: Support the quality oversight with contract testing labs, distributors, and other key external partners.
- Participate in audits of third-party facilities as necessary to verify compliance with cGMP and regulatory requirements.
- Contribute to the preparation for regulatory inspections related to product quality and support responses and follow-up activities.
- Leadership and Contribution to Quality Culture: Serve as a subject matter expert and provide guidance to internal stakeholders on quality best practices, regulatory expectations, and cGMP requirements.
- Support training initiatives and quality improvement projects that strengthen the organization's culture of quality.
- Collaborate crossâfunctionally to uphold compliance standards.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
101-250 employees
