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Senior QA Leader – Phase Biotech, BLA Readiness

Job in Newark, Essex County, New Jersey, 07175, USA
Listing for: Celldex Therapeutics, Inc.
Full Time position
Listed on 2026-06-11
Job specializations:
  • Quality Assurance - QA/QC
    Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 60000 - 80000 USD Yearly USD 60000.00 80000.00 YEAR
Job Description & How to Apply Below
Position: Senior QA Leader – Phase 3 Biotech, BLA Readiness

Celldex Therapeutics, Inc. is seeking a Manager, Quality Assurance to lead the quality assurance for manufacturing operations and the late-stage clinical development of CDX‑0159. The ideal candidate will ensure compliance with FDA regulations and internal quality systems, play a key role in inspections and audits, and support the submission of the Biologics License Application (BLA).

This position requires strong leadership skills, regulatory judgment, and over 8 years of experience in quality assurance within the biopharmaceutical industry. A competitive salary and benefits package is offered.

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Position Requirements
10+ Years work experience
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