Executive Director, Commercial Quality Systems

Celldex Therapeutics, Inc.; Hampton, Northern (VA, KY); Hybrid; USD 234,000 - 303,000; Full time

Job summary

Celldex Therapeutics, Inc. is seeking an Executive Director, Commercial Quality Systems to lead the Quality Management System across commercial and late-stage clinical products in the United States.

You will oversee a growing team of quality leaders and partner with Regulatory Affairs, Manufacturing, and Operations to ensure inspections readiness and regulatory compliance. The role focuses on strategic quality leadership, development of electronic QMS tools, and driving continuous improvement

Qualifications

• BS in a scientific discipline; advanced degree preferred.
• Experience supporting commercial biologics and lifecycle quality activities.
• Expertise with eQMS platforms, quality metrics, and continuous improvement programs.
• Extensive experience 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

• Manage and develop a growing team of Quality leaders.
• Strategic quality leadership of designing, maintaining, and keeping current Celldex's commercial Quality Systems.
• Development and implementation of electronic systems for Celldex's Quality Systems.
• Development of the Inspection Management System for Celldex and its CDMOs to ensure successful Health Authority Inspections.
• Partner with Operations to ensure Celldex develops and maintains appropriate standards for Medical Devices.
• Trend and present Commercial Quality Metrics for Management Review Committee meetings.
• As a part of the Quality Leadership Team, work within the team to drive Strategic Quality initiatives across the organization.
• Develop departmental budgets for the QA department, including defining resources and personnel needs.

Skills

Quality leadership

Regulatory knowledge

eQMS expertise

QMS development

Deviations/CAPA/Change control

Inspection readiness

Cross-functional collaboration

Education

BS in science

Advanced degree preferred

Tools

eQMS platforms

Job description

Overview

The Executive Director, Commercial Quality Systems is responsible for the strategic leadership, development, and continuous improvement of Celldex Therapeutics' Quality Management System (QMS) to support commercial and late-stage clinical products. This role ensures quality systems are compliant with global regulatory requirements, industry standards, and company objectives while fostering a culture of quality and operational excellence. The Executive Director oversees key quality processes, including deviations, CAPA, change control, complaint management, document control, training, and inspection readiness programs. As a senior quality leader, this position partners closely with Regulatory Affairs, Manufacturing, Supply Chain, IT, and Technical Operations to ensure a robust and sustainable quality infrastructure across the organization.

Responsibilities

• Responsible for the management and development of a growing team of (4) Quality leaders. This includes Quality Management, Quality Inspection Management, and Quality Medical Device Management.
• Responsible for the strategic quality leadership of designing, maintaining, and keeping current Celldex's commercial Quality Systems.
• Responsible for the development and implementation of the electronic systems utilized for the facilitation of Celldex's Quality Systems.
• Development of the Inspection Management System for Celldex and its CDMOs to ensure successful Health Authority Inspections.
• Partnering with Operations to ensure Celldex develops and maintains appropriate standards for Medical Devices.
• Trend and present Commercial Quality Metrics for Management Review Committee meetings.
• As a part of the Quality Leadership Team, work within the team to drive Strategic Quality initiatives across the organization.
• Develop departmental budgets for the QA department, including defining resources and personnel needs.

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

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.