Executive Director, Commercial Quality Systems

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

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.

• 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

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.