Quality & Regulatory Director, Cell Therapy

Regulatory Jobs; Florham Park (NJ); On-site; USD 180,000 - 240,000; Full time

Job summary

Celularity is seeking a senior leader to oversee Quality Assurance, Quality Control and Regulatory Affairs in a fast-paced, cell-therapy environment. You will build and sustain GMP-compliant quality systems, manage audits, and drive regulatory submissions with FDA/EMA leadership.

The role requires 10+ years in regulated biotech, strong collaboration across departments, and the ability to guide strategic quality programs in a clinical-stage company committed to regenerative medicine.

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• 10+ years in Quality Assurance, Quality Control, and/or Regulatory Affairs in regulated advanced therapies.
• Experience building GMP-compliant quality systems and regulatory programs in a clinical-stage biotech.
• Strong knowledge of FDA, EMA, GxP and applicable regulatory requirements for development and manufacturing.
• Proven track record supporting regulatory inspections, filings and agency communications.
• Leadership and cross-functional collaboration across teams.

Responsibilities

• Lead and maintain a phase-appropriate QMS covering deviations, CAPAs, change controls, documentation, training, complaints and risk management.
• Provide GMP and GTP quality oversight of operations complying with FDA/EMA and state regulations.
• Review and approve quality records, investigations, batch documentation and product disposition.
• Manage quality supplier program, vendor qualification, audits and external inspection responses.
• Drive audits, inspection readiness and continuous quality improvement initiatives.
• Develop and execute regulatory strategies, submissions, and liaison with authorities.
• Collaborate with cross-functional teams to integrate regulatory requirements into development and manufacturing plans.

Skills

Quality Assurance

Quality Control

Regulatory Affairs

Audits

GxP Compliance

Education

Bachelor's in Life Sciences

Job description

Celularity is seeking a senior leader to oversee Quality Assurance, Quality Control and Regulatory Affairs in a fast-paced, cell-therapy environment. You will build and sustain GMP-compliant quality systems, manage audits, and drive regulatory submissions with FDA/EMA leadership.

The role requires 10+ years in regulated biotech, strong collaboration across departments, and the ability to guide strategic quality programs in a clinical-stage company committed to regenerative medicine.