Quality Systems & Compliance Lead for Cell Therapy (QMS)

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

Job summary

Made Scientific, Inc. seeks a Senior Manager, Quality Systems to lead the Quality Management System (QMS) and related processes across deviation, CAPA, change control, document control, and training.

This role involves hands-on management of Veeva QMS, ensuring GMP compliance and regulatory readiness, and driving continuous improvement within a cell therapy CDMO. The successful candidate will have 5+ years in pharmaceutical/GMP quality systems, strong leadership, and proven experience

Qualifications

• Master’s degree or higher in a scientific discipline with 5+ years in pharmaceutical/GMP.
• Experience in QS with cell therapy preferred.
• Proven experience in QS management including deviations, CAPAs, change control, document management, and training.
• Hands-on QMS implementation experience, preferably Veeva (QMS, Document Control, and Training).
• Deep understanding of cGMP and regulatory frameworks for cell therapy manufacturing.

Responsibilities

• Own the Quality Management System (QMS) with end-to-end accountability for deviations, CAPAs, change control, document management, and training.
• Oversee audits and inspections including preparation, coordination, and action tracking.
• Lead QMS improvement initiatives to ensure regulatory compliance and operational excellence.
• Administer QMS processes and electronic systems to ensure consistent implementation across the organization.
• Collaborate with Technical Operations, Quality, Regulatory Affairs to align QMS with operational needs.

Skills

Quality Systems

QMS ownership

Leadership

Regulatory compliance

GMP knowledge

CAPA management

Deviations handling

Audits & inspections

Document management

Training management

Veeva QMS

Cross-functional collaboration

Education

Master’s degree in a relevant scientific discipline

Bachelor’s degree in science

Tools

Veeva QMS

QMS Document Control

QMS Training modules

TrackWise (preferred)

Job description

Made Scientific, Inc. seeks a Senior Manager, Quality Systems to lead the Quality Management System (QMS) and related processes across deviation, CAPA, change control, document control, and training.

This role involves hands-on management of Veeva QMS, ensuring GMP compliance and regulatory readiness, and driving continuous improvement within a cell therapy CDMO. The successful candidate will have 5+ years in pharmaceutical/GMP quality systems, strong leadership, and proven experience