Senior Quality Systems Leader – Cell Therapy QMS

Made Scientific; Princeton (NJ); On-site; USD 150,000 - 210,000; Full time

Job summary

Made Scientific, a US-based cell therapy CDMO, seeks a Senior Manager, Quality Systems to own the Quality Management System (QMS) and drive regulatory compliance across GMP operations. You will manage Veeva QMS, document control, deviation/CAPA processing, change control, and internal audits, partnering with operations, MSAT and Regulatory Affairs.

You bring 5+ years in QS within biopharma or cell therapy, with hands-on QMS implementation experience, strong leadership, and a track record

Qualifications

• Master's or equivalent in a scientific discipline with 5+ years in GMP/pharma.
• Hands-on QMS experience, including deviations, CAPA, and change control.
• Experience implementing QMS frameworks in cell therapy or biopharma.

Responsibilities

• Own the Quality Management System (QMS) and ensure regulatory compliance.
• Manage deviations, CAPAs, change control, document management, and training.
• Lead internal audits and coordinate inspections with regulatory bodies and clients.
• Develop and monitor quality metrics and KPI reporting.
• Lead cross-functional quality initiatives with MSAT, Regulatory, and Operations.
• Facilitate QMS governance forums and drive continuous improvement.

Skills

QMS ownership

Veeva QMS

CAPA management

Deviation management

Audit management

Change control

Document control

Training management

Education

Master’s degree in a scientific discipline

Bachelor’s degree in a relevant science

Tools

Veeva Quality Suite

Job description

Made Scientific, a US-based cell therapy CDMO, seeks a Senior Manager, Quality Systems to own the Quality Management System (QMS) and drive regulatory compliance across GMP operations. You will manage Veeva QMS, document control, deviation/CAPA processing, change control, and internal audits, partnering with operations, MSAT and Regulatory Affairs.

You bring 5+ years in QS within biopharma or cell therapy, with hands-on QMS implementation experience, strong leadership, and a track record