Director, Quality and Regulatory

About Celularity

Celularity Inc. (Nasdaq: CELU) is a longevity-focused regenerative and cellular medicine company developing and manufacturing allogeneic and autologous cell therapies derived from the postpartum placenta. Celularity leverages the placenta’s unique biology, immunologic properties and scalable availability to develop therapeutic solutions targeting fundamental mechanisms of aging and age-related disease.

Quality Assurance

• Lead and maintain a phase-appropriate Quality Management System (QMS) overseeing core quality processes including but not limited to deviations, CAPAs, change controls, document management, training, complaints and risk management.
• Provide GMP and GTP quality oversight of internal operations ensuring compliance with FDA, EMA, all applicable GxP regulations, select state regulations and accrediting bodies
• Review and approve quality records, including investigations, batch documentation, validation packages and product disposition.
• Manage and oversee the quality supplier program, quality agreements, vendor qualification activities and routine external audits.
• Drive inspection readiness and lead all internal/external audits, responses to regulatory inspections, partner audits and quality improvement initiatives.

Quality Control

• Develop and execute analytical and microbiological quality control strategy supporting product development, manufacturing and clinical/investigational supply.
• Oversee internal and external laboratory activities, including routine product testing, product visual inspection, microbiological testing, raw material testing and overall laboratory compliance programs.
• Ensure timely execution of product testing, visual inspection and review of analytical and microbiological data supporting raw material qualification, batch release, stability programs and specification management.
• Management of the environmental monitoring program, cleanroom sampling and contamination control strategies.
• Oversight of external contract testing organizations.
• Establish quality metrics, trending programs and continuous improvement initiatives to ensure product quality and compliance.

Regulatory

• Develop and execute regulatory strategies supporting process development, manufacturing operations and commercialization.
• Lead preparation, submission and maintenance of regulatory filings, including INDs, amendments, annual reports, meeting packages and designation applications.
• Serve as the primary liaison with regulatory authorities, coordinating responses and agency communications.
• Monitor emerging regulatory requirements and industry trends assessing impact to business. Drive compliance update activities.
• Partner with cross-functional teams to ensure regulatory requirements are assessed and incorporated into development, clinical and manufacturing planning.