Executive Director, Commercial Quality Systems

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

Job summary

Celldex Therapeutics is seeking an Executive Director, Commercial Quality Systems to lead the design, development, and ongoing enhancement of the company’s global Quality Management System supporting commercial and late-stage clinical products.

You will oversee deviations, CAPA, change control, complaint management, document control, training, and inspection readiness, while developing electronic QMS platforms and incident management strategies.

Qualifications

• Oversee key quality processes including deviations, CAPA, change control, complaint management, document control, training, and inspection readiness.
• Lead a four-person quality leadership team across Quality Management, Inspection, and Medical Devices.
• Develop and implement electronic QMS systems and inspection management strategies.
• Partner cross-functionally with Regulatory, Manufacturing, Supply Chain, IT, and Operations.
• Monitor quality metrics, drive strategic initiatives, and manage departmental budgets.

Responsibilities

• Design and enhance Celldex's global QMS to support commercial and late-stage products.
• Lead audit readiness, inspections, deviations, CAPA programs.
• Develop and implement electronic QMS systems.
• Collaborate cross-functionally with Regulatory, Manufacturing, IT, and Operations.
• Oversee budget for the quality organization.

Skills

Deviation management

CAPA programs

Change control

Complaint handling

Document control

Training & development

Inspection readiness

Education

BS in a scientific discipline

Advanced degree preferred

Tools

Electronic QMS platforms

Inspection management systems

Job description

Role: Executive Director, Commercial Quality Systems, leading the design, development, and continuous enhancement of Celldex's global Quality Management System (QMS) to support commercial and late-stage clinical products.

• oversee key quality processes including deviations, CAPA, change control, complaint management, document control, training, and inspection readiness
• manage and develop a team of four quality leaders across Quality Management, Inspection, and Medical Devices
• develop and implement electronic QMS systems and inspection management strategies
• partner cross-functionally with Regulatory, Manufacturing, Supply Chain, IT, and Operations
• monitor quality metrics, drive strategic initiatives, and manage departmental budgets

• BS in a scientific discipline with advanced degree preferred
• extensive experience supporting commercial biologics, product lifecycle quality, and enterprise QMS
• strong knowledge of FDA, EMA, ICH, and GxP regulations
• proven experience with audit readiness, inspections, deviations, CAPA, and quality systems management
• prior success leading high-performing quality teams

High-Value: focus on biologics and commercial product lifecycle, global regulatory compliance, electronic QMS platforms, inspection management, and cross-functional collaboration.

WorkSetup: not specified; salary range $233,631–$303,417.