Executive Director, Quality CDMO Management

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

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.