Director, Inspection Readiness & Quality Compliance

Celldex Therapeutics, Inc.

Hampton, Northern (VA, KY)

Hybrid

USD 177,000 - 229,000

Full time

14 days+

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Job summary

Celldex Therapeutics, Inc. is seeking a Director to architect and lead its inspection management program, ensuring readiness for FDA/International inspections, partner audits, and commercial launch activities.

The role collaborates across Quality, Manufacturing, Regulatory Affairs, Clinical Development, and Commercial functions to sustain a robust inspection readiness framework, supporting Celldex's move toward commercial operations while maintaining global regulatory compliance.

Qualifications

10+ years in QA, GMP compliance, regulatory inspection management, or quality systems.
Experience leading FDA and international regulatory inspections.
Direct experience with CMOs and global supply networks.
Experience managing Health Authority responses and CAPA follow ups.
Biologics, monoclonal antibodies, sterile products, or advanced therapeutics preferred.
Clinical-stage and commercial-stage environment experience preferred.

Responsibilities

Create an Inspection Management Program for Celldex and CDMOs.
Create a living inspection readiness program for Celldex and CDMOs.
Work with the Quality CDMO Management team on Health Authority inspection topics.
Establish a Health Authority Inspection Management Process for Celldex and CDMOs.
Oversee responses to Health Authority inspections.
Ensure CAPA follow-ups are completed on time (100%).
Develop metrics to track performance.