Quality Systems Senior Manager

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.

The Senior Manager, Quality Systems, will serve as the primary point of contact for the execution and oversight of the company’s Quality Management System (QMS) and associated quality processes. This role is highly hands‑on, with responsibility for managing Veeva QMS, training, document control, deviation and CAPA processing, change control, and internal audit activities, ensuring full compliance with GMP and regulatory requirements.

The ideal candidate has deep expertise in quality systems and experience building or implementing QMS frameworks from the ground up in a regulated biopharmaceutical or cell therapy environment.

Quality Management System (QMS) Ownership — Serve as the primary process owner with end‑to‑end accountability for the following elements:

• Deviation Management — Manage the deviation process and system, ensuring timely documentation, investigation, root cause analysis, and appropriate CAPA linkage.
• CAPA Management — Oversee the CAPA process and system, ensuring effective creation, implementation, and verification of corrective and preventive actions.
• Audits & Inspections — Own the audit and inspection process, including preparation coordination, scheduling, execution support, communication management, and tracking of findings and follow‑up actions for regulatory, client, and internal audits.
• Change Control — Manage the change control process and system, ensuring controlled initiation, review, approval, and closure of changes.
• Document Management — Maintain a compliant document control system for authoring, reviewing, approving, issuing, and archiving controlled documents.
• Training Management — Administer the GMP training program to ensure role‑based compliance and ongoing personnel qualification.
• QMR Process — Facilitate and own the Quality Management Review (QMR) process, including preparation, coordination, documentation, and communication of QMS performance to leadership and stakeholders.

• Responsible for establishing, administering, and continuously enhancing the Quality Management System (QMS) to ensure regulatory compliance, system maturity, and operational excellence.
• Establish, implement, and maintain an integrated Quality Management System (QMS) in alignment with FDA, EMA, ICH, and internal quality standards.
• Serve as the system administrator and process owner for Veeva Quality Suite, ensuring system integrity, harmonized workflows, and effective end‑user adoption.
• Develop, monitor, and report Quality Metrics and KPIs to assess system performance, drive data‑driven decision‑making, and support continuous improvement.
• Lead cross‑functional process improvement initiatives to optimise quality workflows, strengthen compliance, and enhance operational efficiency.
• Facilitate formal Quality governance forums (e.g., Quality Council, Change Control Board, CAPA Review Board), including agenda setting, meeting facilitation, documentation of decisions, and action item tracking.
• Provide training, guidance, and subject matter expertise on QMS processes and electronic systems to ensure consistent implementation across the organization.

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