Global CDMO Quality & Compliance Executive

Celldex Therapeutics, Inc.; Hampton, Northern (VA, KY); Hybrid; USD 234,000 - 303,000; Full time

Job summary

Celldex Therapeutics, Inc. is seeking an Executive Director, Quality CDMO Management to lead quality operations across external CDMOs in the US and Europe, ensuring compliance with FDA/EMA and Celldex standards.

The role partners with internal teams to drive risk management, audit readiness, vendor performance, and continuous improvement for clinical and commercial programs. You will build and oversee a growing quality leadership team, manage supplier quality programs, and lead regulatory

Qualifications

• BS in a scientific discipline required; advanced degree preferred.
• Extensive experience overseeing CDMO/CMO quality operations across commercial drug substance and drug product.
• Strong experience with biologics manufacturing, quality systems, deviations, CAPA, and change control.
• Expert knowledge of FDA, EMA, ICH, and global GMP/GxP regulations.
• Proven track record managing supplier quality programs, vendor audits, and quality agreements.
• Demonstrated success leading regulatory inspections and maintaining inspection readiness.

Responsibilities

• Responsible for the Strategic Quality Oversight of all Commercial CDMO activity for the Celldex Supply Chain. This includes sites in the U.S. and Europe.
• Create a program for how to effectively manage our CDMO network for Quality.
• Effectively communicate with CDMOs to build relationships and to work towards the on-time, compliant, quality delivery of our products.
• Work cross-functionally within the Celldex organization to facilitate CDMO delivery.
• Provide Quality leadership on key Quality events occurring at our CDMOs to ensure Quality and Compliance are effectively met.
• Provide Quality Metrics for CDMO performance.
• Development of a growing staff of (4) Quality Leaders.
• Will require on-site oversight depending on business needs.

Job description

Celldex Therapeutics, Inc. is seeking an Executive Director, Quality CDMO Management to lead quality operations across external CDMOs in the US and Europe, ensuring compliance with FDA/EMA and Celldex standards.

The role partners with internal teams to drive risk management, audit readiness, vendor performance, and continuous improvement for clinical and commercial programs. You will build and oversee a growing quality leadership team, manage supplier quality programs, and lead regulatory