Senior Quality Systems Leader – Cell Therapy QMS

Made Scientific; Princeton (NJ); On-site; USD 140,000 - 190,000; Full time

Job summary

Made Scientific is seeking a Senior Manager, Quality Systems, to lead the QMS and related quality processes across GMP-compliant cell therapy operations in the US. You will manage Veeva QMS, training, document control, deviations, CAPAs, change control, and internal audits, ensuring regulatory alignment and continuous improvement.

The role requires hands-on leadership, cross-functional collaboration, and the ability to implement QMS frameworks from the ground up within a regulated biopharma/cell

Qualifications

• Master’s degree in a relevant scientific discipline with 5+ years in pharma/GMP, or a BA with 7+ years of experience.
• Experience in QS management with deviations, CAPAs, change control, doc management, and training.
• Hands-on QMS implementation experience, preferably Veeva (QMS, Document Control, Training).
• Strong knowledge of cGMP and cell therapy regulatory frameworks.

Responsibilities

• Own QMS processes with end-to-end accountability for deviations, CAPA, audits, change control, and documentation.
• Lead QMS improvements, metrics, KPIs, and governance forums like Quality Council and CAPA Review Board.
• Collaborate with operations, MSAT, and Regulatory Affairs to ensure compliant workflows.
• Provide SME guidance and training on QMS processes and electronic systems.

Skills

Quality Systems

Project Leadership

Regulatory Knowledge

Analytical Skills

Cross-functional Collaboration

Education

Master’s degree in a relevant science

Bachelor’s degree with 7+ years’ experience

Tools

Veeva QMS

Document Control System

CAPA Tracking

Job description

Made Scientific is seeking a Senior Manager, Quality Systems, to lead the QMS and related quality processes across GMP-compliant cell therapy operations in the US. You will manage Veeva QMS, training, document control, deviations, CAPAs, change control, and internal audits, ensuring regulatory alignment and continuous improvement.

The role requires hands-on leadership, cross-functional collaboration, and the ability to implement QMS frameworks from the ground up within a regulated biopharma/cell