Senior Director of Quality for CDMO Partnerships

Celldex; Hampton (NJ); On-site; USD 234,000 - 303,000; Full time

Job summary

Celldex Therapeutics seeks an Executive Director, Quality CDMO Management to lead quality across its external CDMO network, ensuring manufacturing, testing, and supply activities meet global GxP, Celldex standards, and regulatory expectations.

The role partners across functions to drive quality risk management, audit readiness, vendor performance, and continuous improvement, with on-site oversight as needed to ensure reliable product supply for clinical and commercial programs.

Qualifications

• BS in a scientific discipline required; advanced degree preferred.
• Extensive CDMO/CMO quality operations experience.
• Biologics manufacturing, quality systems, deviations, CAPA, and change control.
• Expert knowledge of FDA, EMA, ICH, and GMP/GxP regulations.
• Proven record managing supplier quality programs and vendor audits.
• Regulatory inspections and inspection readiness experience.

Responsibilities

• Strategically oversee Commercial CDMO quality across sites in the U.S. and Europe.
• Design and manage the CDMO quality oversight program.
• Communicate with CDMOs to ensure on-time, compliant, quality delivery.
• Collaborate cross-functionally to enable CDMO performance.
• Provide leadership during quality events and ensure compliance.
• Deliver quality metrics for CDMO performance.
• Develop and grow a team of four Quality Leaders.
• Provide on-site oversight as needed.

Skills

Quality leadership

CDMO oversight

Cross-functional collaboration

Regulatory inspections

Quality metrics

Education

BS in scientific discipline

Advanced degree preferred

Job description

Celldex Therapeutics seeks an Executive Director, Quality CDMO Management to lead quality across its external CDMO network, ensuring manufacturing, testing, and supply activities meet global GxP, Celldex standards, and regulatory expectations.

The role partners across functions to drive quality risk management, audit readiness, vendor performance, and continuous improvement, with on-site oversight as needed to ensure reliable product supply for clinical and commercial programs.