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 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.
Key Responsibilities
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.
QMS Implementation and Continuous Improvement
- 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 optimize 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.
Cross-Functional Collaboration & Support
- Collaborate with Technical Operations, Quality, MSAT, and Regulatory Affairs to ensure effective implementation of QMS processes and alignment with operational needs.
- Provide subject matter expertise and support to cross-functional teams to drive consistent application of quality standards and ensure right-first-time execution.
- Serve as a quality point of contact during operational discussions, supporting proactive issue resolution and compliance-focused decision-making.
Required Qualifications
- Master’s degree in a relevant scientific discipline with 5+ years of experience in the pharmaceutical or GMP industry, or a Bachelor's degree with 7+ years of relevant experience.
- Several years of experience in QS, with experience in the cell therapy industry preferred.
- Proven experience in QS management, with direct accountability for deviations, CAPAs, change control, document management, and training.
- Hands-on experience with QMS implementation, preferably Veeva (QMS, Document Control, and Training modules).
- In-depth understanding of cGMP principles and regulatory frameworks relevant to cell therapy manufacturing.
- Strong leadership, communication, and analytical skills with the ability to collaborate effectively across all levels of the organization.
- Highly organized, detail-oriented, and capable of managing multiple priorities in a fast-paced environment.
- Skilled in interacting with clients and health authorities, with strong verbal and written communication
Preferred Qualifications
- Experience in cell therapy, ATMP, or CDMO operations.
- Experience leading electronic QMS implementations (Veeva, Trackwise, or equivalent).
- ASQ Certified Quality Auditor (CQA) certification.
- Working knowledge of ICH Q7, Q8, Q9, and Q10 principles.
Required Degree
- B.S
Physical Requirements
- Ability to perform job functions in compliance with applicable standards, including productivity and attendance expectations. Must be flexible to work in various environments, including gowning for a CNC/ISO8 facility, lifting up to 25 lbs., and performing physical tasks such as bending, standing, and working with cell-based products or chemicals