Executive Director, Quality CDMO Management

About the role

This role provides strategic leadership and oversight of quality operations across Celldex Therapeutics’ external contract development and manufacturing organization (CDMO) network. The Executive Director 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 position 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 role 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

• Provide strategic quality oversight of all commercial CDMO activity for the Celldex supply chain, including sites in the U.S. and Europe.
• Create and implement a program for effectively managing the CDMO network for quality.
• Communicate with CDMOs to build relationships and ensure on-time, compliant, and quality delivery of products.
• Work cross-functionally within Celldex to facilitate CDMO delivery.
• Provide quality leadership on key quality events at CDMOs to ensure compliance and quality standards are met.
• Develop and report quality metrics for CDMO performance.
• Build and develop a growing team of quality leaders (currently 4).
• Conduct on-site oversight as needed based on business requirements.

Qualifications

• BS in a scientific discipline required; advanced degree preferred.
• Extensive experience overseeing CDMO/CMO quality operations for 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.

Pay

The expected base salary for this position is $233,631 to $303,417.

Benefits

• Annual discretionary bonus.
• Long-term incentive compensation.
• 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 benefits can be found on the Celldex careers page.