ASSOCIATE DIRECTOR, PRODUCT QUALITY

at  Capricor Inc

Position: Associate Director, Product Quality
The Associate Director of Product Quality will lead and oversee quality operations to ensure compliance with cGMP standards, regulatory requirements, and industry best practices in support of our cell therapy programs. This role is instrumental in establishing and executing product quality strategies to support clinical and commercial production, ensuring that all products meet stringent quality standards. The position requires working cross-functionally across all sites, program teams, and other functions to successfully deliver corporate goals, production plans and quality objectives.

BASIC REQUIREMENTS:

• Bachelor’s degree in Life Sciences, Biotechnology, or a related field (advanced degree preferred).
• 10+ years of experience in quality assurance or quality control, with a focus on cell therapy, gene therapy, biologics, or similar fields within the biotech or pharmaceutical industry.
• In-depth knowledge of cGMP regulations, FDA/EMA guidelines, and ICH Q-series guidelines for cell-based and biologic products.
• Demonstrated experience managing product quality in clinical and commercial settings, including batch release, deviation management, and regulatory inspections.
• Strong leadership skills with experience managing teams, fostering collaboration, and working effectively in a fast-paced, cross-functional environment.
• Excellent written and verbal communication skills with the ability to clearly articulate quality standards and expectations.

PREFERRED QUALIFICATIONS:

• Experience with aseptic processing, sterility assurance, and quality control testing for cell therapies.
• Knowledge of quality systems specific to cell therapy and regenerative medicine.
• Familiarity with regulatory requirements for autologous and allogeneic cell-based therapies.

• Quality Management and Oversight:
• Ensure cGMP compliance throughout all stages of product development, from early phase through commercialization.
• Lead investigations into product quality issues, deviations, CAPAs, and change controls, ensuring effective root cause analysis and timely resolution.
• Collaborate closely with cross-functional teams (Manufacturing, Regulatory, R&D, Clinical) to align quality processes with overall company objectives and regulatory expectations.
• Product Quality Assurance:
• Establish robust quality assurance protocols for cell therapy products to ensure consistent safety, efficacy, and purity.
• Oversee QC testing activities, including the coordination of in-process, release, and stability testing for cell-based products.
• Evaluate and approve product specifications, sampling plans, and analytical methods in collaboration with QC teams.
• Lead regular quality reviews of product performance data to identify trends, support continuous improvement, and implement corrective actions as needed.
• Supplier and External Partner Management:
• Develop and maintain a high standard of quality oversight with contract manufacturing organizations (CMOs), contract testing labs, and other key external partners.
• Conduct audits of third-party facilities as necessary to verify compliance with cGMP and regulatory requirements.
• Act as a key liaison with regulatory bodies and prepare for, host, and respond to regulatory inspections related to product quality.
• Leadership and Development:
• Manage and mentor a team of quality professionals, fostering a culture of quality, accountability, and continuous improvement.
• Provide guidance and training on quality best practices, regulatory updates, and cGMP requirements to internal stakeholders.
• Actively participate in company initiatives to support a culture of quality, including training programs and quality improvement projects.