Overview In this role you drive the strategic leadership and ongoing enhancement of Celldex's Commercial Quality Management System to support commercial and late-stage clinical products. You will partner across Regulatory Affairs, Manufacturing, Supply Chain, IT, and Technical Operations to ensure a robust quality infrastructure. You handle key quality processes and foster a culture of quality and operational excellence. Your work enables compliant, inspection-ready operations and scalable systems at a global level. This is a high-impact opportunity to shape quality strategy, systems, and readiness at scale.
Compensation / Benefits- base salary (US$233,631-US$303,417)
- annual discretionary bonus
- long-term incentive
- 401(k) with employer contribution
- health care and other insurance
- paid holidays, vacation, and sick days
Responsibilities- Lead and grow a Quality Leadership team (4 managers) across Quality Management, Quality Inspection Management, and Quality Medical Device Management
- Provide strategic direction for maintaining and updating Celldex's commercial Quality Systems
- Oversee development and deployment of electronic quality systems
- Develop the Inspection Management System for Celldex and CDMOs to ensure successful Health Authority inspections
- Collaborate with Operations to establish standards for Medical Devices
- Trend and present commercial quality metrics for management review
- Contribute to Strategic Quality initiatives as part of the Quality Leadership Team
- Develop departmental QA budgets and resource planning
Key requirements- BS in a scientific discipline; advanced degree preferred
- Experience supporting commercial biologics and product lifecycle quality activities
- Expertise with eQMS platforms, quality metrics, and continuous improvement
- Extensive experience managing enterprise QMS
- Strong knowledge of FDA, EMA, ICH, and global GxP 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 teams
- leadership
- cross-functional collaboration
- strategic thinking
- eQMS platforms
- Quality Management Systems
- deviations, CAPA, change control, complaints, document control, training systems
