New · posted Oct 15
Celularity · Biotechnology
Director, Quality and Regulatory
- Florham Park, NJ
- On-site
- Full-time
- Director
Open until filled
The role
Description
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.
What you need
Minimum Qualifications (Must have)
- Bachelor’s degree in Life Sciences, Engineering, or related scientific discipline
- 10+ years’ of progressive experience in Quality Assurance, Quality Control, and/or Regulatory Affairs within regulated advanced therapeutic industries
- Demonstrated experience developing, maintaining and leading GMP-compliant quality systems and regulatory programs in a clinical-stage biotechnology environment
- Strong working knowledge of FDA, EMA, GxP and any applicable regulatory requirements governing product development and manufacturing. Expertise leading and managing internal and external audits of these regulations
- Successful track record supporting regulatory inspections, regulatory filings, agency communications, commercial readiness activities or product approvals.
- Strong leadership, adaptability, communication and cross-functional collaboration skills with the ability to influence stakeholders at all organizational levels
Preferred Qualificationsnice to have
- Direct experience supporting cell therapy, gene therapy, tissue engineering, regenerative medicine and/or biologics
- Experience in a fast-paced, scientific, start-up environment
- Dynamic individual with the ability to communicate and engage others.
- Independent and self-starting.
- Eager and adaptable.
Pay
$190,000 – $230,000 a year
Employer providedWhere you'll work
Florham Park, NJOn-siteOpen in Maps (opens in a new tab)
More jobs in Florham Park, NJWorking conditions
- Position primarily supports classified laboratory environments.
- May be required to gown aseptically.
- Open office environment outside of laboratory zones
- Fast paced, start-up environment which may periodically require work beyond standard business hours. Flexible schedule.
***THIS ROLE DOES NOT PROVIDE RELOCATION
***NO AGENCIES PLEASE
From the posting
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.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is level with the US median for Quality Assurance roles at this level.
This roleEmployer provided
Director roles in New Jersey9 roles publishing pay
Director roles in the US102 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $190,000 | — | $230,000 |
| New Jersey (middle half) | $177,000 | $209,000 | $210,000 |
| All US (middle half) | $186,500 | $209,250 | $231,375 |
This role: Celularity's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Celularity's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 28 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance10
- Collaboration and leadership8
- Lab testing and methods4
- Documentation and SOPs4
- Quality systems and risk4
- Investigations and CAPA3
- Validation and qualification3
- Regulatory submissions3
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- FDAFDA IND(official source, opens in a new tab)Investigational New Drug applications
Company hiring pulse
Celularity on Regulatory Jobs
- 3
- Open roles
- 3
- Distinct roles
- 1
- Locations
By discipline
- Quality3 100%
By level
- Senior & Principal2 67%
- Director1 33%
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Director, Quality and Regulatory at Celularity
Open until filled. $190K–$230K a year, employer provided.