Lead, Quality Assurance

CELULARITY LLC; Florham Park (NJ); On-site; USD 140,000 - 180,000; Full time

Job summary

Celularity Inc. is seeking a Lead, Quality Assurance to uphold clinical and commercial product quality through QA review of records, batch documentation, QC data, and donor eligibility records.

You will support QMS processes, SOPs, training, and regulatory interactions to ensure Celularity quality standards are met. The role requires deep knowledge of cGMP/GTP, CAPA workflows, investigations, and audits, with a focus on ensuring inspection readiness across product areas and cross-functional

Qualifications

• Bachelor’s degree in a scientific discipline is required.
• Minimum of 5+ years of QA experience in a cGMP environment.
• Familiarity with cGMP and GTP environments.
• Ability to interpret and apply good laboratory practices.
• Knowledge of OOS, OOT, CAPA and investigations.
• Strong organizational, teamwork and communication skills.
• Independent and self-starting, adaptable, with attention to detail.
• Ability to don PPE as required.

Responsibilities

• Conduct QA review of product records, biobanking files, batch documentation and QC/environmental data.
• Review batch-related documentation and support product release decisions.
• Issue batch records and verify labeling and packaging.
• Support incoming materials inspection and resolve discrepancies.
• Manage quality events, CAPA, investigations and follow-up.
• Write, review, and approve SOPs and related documents.
• Provide QA guidance to cross-functional partners and be QA contact for areas.
• Participate in audits and regulatory interactions as needed.

Skills

Quality Assurance

cGMP

OOS/OOT

CAPA

Regulatory compliance

Documentation control

Education

Bachelor's degree

Job description

Description

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.

Requirements

Minimum Qualifications (Must have)

• Bachelor’s degree in scientific discipline required.
• Minimum of 5+ years of quality assurance experience in a cGMP-regulated environment.
• Familiarity with cGMP and GTP environments
• Ability to understand, follow, interpret and apply good laboratory practices.
• Knowledge of OOS, OOT, investigation, and CAPA processes.
• Strong organizational and time management skills
• Ability to work well in a team environment
• Dynamic individual with the ability to communicate and engage others
• Independent and self-starting.
• Eager and adaptable
• Excellent verbal and written communication skills as well as strong focus and attention to detail.
• Ability to don personal protective equipment (PPE) during various role responsibilities

Celularity Inc. is an equal opportunity employer

***THIS ROLE DOES NOT PROVIDE RELOCATION