Executive Director, Quality CDMO Management

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

Overview

The Executive Director, Quality CDMO Management at Celldex Therapeutics is responsible for providing strategic leadership and oversight of quality operations across the company’s external contract development and manufacturing organization (CDMO) network. This role ensures that all manufacturing, testing, and supply activities conducted by third-party partners comply with global GxP regulations, Celldex quality standards, and regulatory expectations. The Executive Director serves as a key cross-functional leader, driving quality risk management, audit readiness, vendor performance, and continuous improvement initiatives to support clinical and commercial development programs. Additionally, the position builds strong relationships with internal and external stakeholders to ensure reliable product supply, regulatory compliance, and successful execution of Celldex’s development and business objectives.

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.

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.

Compensation Statement

The expected base salary for this position is: $233631.00 to $303417.00. We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market. Subject to eligibility and applicable plan terms, compensation includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.