Head of Commercial Quality Systems & Regulatory

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

Benefits offered by this job

Base salary + annual bonus

Long-term incentive

401(k) with employer contribution

Health care and other benefits

Paid holidays, vacation, and sick days

Job summary

Celldex Therapeutics is seeking an Executive Director, Commercial Quality Systems in New Jersey to lead the Quality Management System across commercial and late-stage products. This senior role partners with Regulatory Affairs, Manufacturing, and IT to ensure a robust quality infrastructure and regulatory readiness.

The position emphasizes managing a Quality Leadership Team, implementing eQMS platforms, and driving continuous improvement and compliance with FDA, EMA, and global GxP standards.

Qualifications

• BS in a scientific discipline required; advanced degree preferred.
• Experience supporting commercial biologics and product lifecycle quality activities.
• Expertise with eQMS platforms, quality metrics, and continuous improvement programs.
• Extensive expertise developing and managing enterprise Quality Management Systems (QMS).
• Strong knowledge of FDA, EMA, ICH, and global GxP regulatory requirements.
• Proven experience with deviations, CAPA, change control, complaints, document control, and training systems.
• Demonstrated success leading regulatory inspections, audit readiness, and compliance initiatives.
• Proven success leading and developing high-performing quality organizations, including direct management of managers and cross-functional team

Responsibilities

• Oversee a growing team of 4 Quality leaders and related quality functions.
• Lead strategic quality leadership for Celldex’s commercial QMS.
• Develop and implement electronic systems for Quality Systems.
• Develop Inspection Management System for internal and CDMO inspections.
• Partner with Operations to set standards for Medical Devices where applicable.
• Track and present commercial quality metrics for leadership reviews.
• Drive Strategic Quality initiatives across the organization.
• Develop departmental budgets and resource plans.

Skills

Quality leadership

Regulatory knowledge

Quality systems development

Team management

Education

BS in scientific discipline

Advanced degree preferred

Tools

eQMS platforms

Job description

Celldex Therapeutics is seeking an Executive Director, Commercial Quality Systems in New Jersey to lead the Quality Management System across commercial and late-stage products. This senior role partners with Regulatory Affairs, Manufacturing, and IT to ensure a robust quality infrastructure and regulatory readiness.

The position emphasizes managing a Quality Leadership Team, implementing eQMS platforms, and driving continuous improvement and compliance with FDA, EMA, and global GxP standards.