Executive Director, Quality CDMO Management

Scorpion Therapeutics; Hampton (NJ); On-site; USD 180,000 - 260,000; Full time

Job summary

Celldex is seeking an Executive Director, Quality CDMO Management to oversee quality operations across Celldex's global external manufacturing network.

You will develop strategies for quality oversight of commercial CDMOs in the U.S. and Europe, manage vendor relationships, ensure GxP compliance, lead quality events, and build a high-performing quality leadership team with on-site oversight as needed.

Qualifications

• Experience managing CDMO/CMO quality functions in biologics manufacturing.
• Strong knowledge of FDA, EMA, ICH and GMP/GxP standards.
• Proven track record in supplier quality, audits and regulatory inspections.

Responsibilities

• Develop strategies for quality oversight of commercial CDMOs in the U.S. and Europe.
• Manage vendor relationships and facilitate cross-functional collaboration.
• Ensure compliance with GxP regulations and lead quality events.
• Provide performance metrics and build a team of quality leaders.
• On-site oversight as needed.

Education

BS in a scientific discipline

Advanced degree

Job description

Role: Executive Director, Quality CDMO Management, overseeing quality operations across Celldex's global external manufacturing network.

Responsibilities

Developing strategies for quality oversight of commercial CDMOs in the U.S. and Europe, managing vendor relationships, facilitating cross-functional collaboration, ensuring compliance with GxP regulations, leading quality events, providing performance metrics, building a team of quality leaders, with on-site oversight as needed.

Requirements

BS in a scientific discipline; extensive experience managing CDMO/CMO quality functions, particularly in biologics manufacturing; strong knowledge of FDA, EMA, ICH, and GMP/GxP standards; proven track record in supplier quality, audits, and regulatory inspections.

Preferred qualifications

Advanced degree and leadership in quality systems, deviations, CAPA, and change control.

High-Value

Biologics manufacturing, GxP compliance, global regulatory standards, cross-functional vendor management, and quality leadership at senior level.

WorkSetup

on-site presence required; location not specified.