Lead Quality Assurance — Cell Therapy & GMP Compliance

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

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