Lead, Quality Assurance
Summary
Lead Quality Assurance role at Celularity reviewing batch records and product-related documentation to support batch disposition and product release of cell therapies. Drives QMS processes including change controls, CAPAs, audits, and SOP reviews in compliance with cGMP, GTP, and FDA regulations.
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.
Purpose
The Lead, Quality Assurance (QA) is responsible for supporting clinical and commercial product quality through QA review of product-related records, batch documentation, QC and environmental monitoring data, donor eligibility records, and other quality documentation to support batch disposition and product release. This role also supports QMS processes, including controlled document review and approval, SOP periodic review, training assignments, and training compliance, while supporting change controls, investigations, OOS/OOT events, CAPA activities, audits, regulatory interactions and cross-functional QA guidance to maintain compliance with cGMP, GTP, applicable health authority regulations, and Celularity quality standards.
Role & Responsibilities
- Conducts QA review of product-related records, biobanking files, transplantation documentation, batch records, QC/environmental monitoring data, donor eligibility records, calibration records, and validation documentation for completeness, accuracy, compliance, and applicable trends.
- Reviews batch-related documentation, makes quality decisions supporting product release, performs batch disposition, and verifies completion of associated quality event activities.
- Issues batch records and labels and conducts QA verification and reconciliation of product packaging and labeling.
- Supports incoming materials inspection and release and resolves documentation errors or discrepancies with appropriate personnel.
- Handles product-related quality events, including change controls, investigations, OOS/OOT events, CAPA coordination, follow-up, action-item tracking, and timely closure.
- Writes, reviews, and approves SOPs and associated documents, including work procedures and forms, and provides input to improve processes and procedures.
- Serves as a QA/QMS approver for controlled documents, including SOPs, work instructions, forms, and related procedural documents, ensuring appropriate review, approval, effectiveness, and alignment with applicable quality system requirements.
- Supports administration of QMS processes such as document control, training assignments, periodic SOP reviews, and training compliance to maintain inspection readiness and procedural effectiveness.
- Implements and ensures adherence to applicable Health Authority regulations, cGMP & GTP requirements, and Celularity quality standards.
- Supports self-inspections, external audits, regulatory filings, and interactions with FDA, partners, and inspectors; serves as audit host as needed.
- Provides day-to-day QA guidance to peers and cross-functional partners and serves as QA point of contact for assigned product or operational areas.
- Completes job-related training in electronic database systems, GMP, safety, and Ethics & Compliance requirements.