Site Lead, Quality Operations & GMP Compliance

Job Description

About Made Scientific

Made Scientific is a leading US-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, and release of autologous and allogeneic cell therapy products for clinical-and-commercial supply. Operating from two U.S.-based manufacturing facilities, Made Scientific combines the agility and entrepreneurial spirit of a specialist CDMO with the global expertise and resources of GC Corporation of South Korea, a global leader in the pharmaceutical and biotechnology sectors.

Position Summary

The Site Lead, Quality Operations & GMP Compliance will serve as the quality leader for the Princeton, NJ site, with direct responsibility for Quality Operations (QO) and overall accountability for site GMP compliance. This role provides quality oversight of GMP execution within Technical Operations, ensuring robust quality engagement and compliance across the full product lifecycle. Acting as the site’s primary quality representative to regulators, clients, and senior leadership, this leader will champion a proactive culture of quality, transparency, and operational excellence.

Key Responsibilities

Site Quality Leadership & Compliance

• Ensure site-wide GMP compliance and product quality at the Princeton, NJ facility
• Oversee GMP execution across Technical Operations, supply chain, and support functions with appropriate process controls
• Partner with site and quality leadership to maintain a phase-appropriate, risk-based Quality Management System (QMS)
• Serve as site lead during regulatory inspections and client audits, ensuring preparedness, clear communication, and successful outcomes

Direct Leadership of Quality Operations

Client Support

Leadership & Collaboration

Required Qualifications

Preferred Qualifications

Physical Requirements

Work Schedule