Manager, Quality Engineering

Made Scientific is a leading U.S.

-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, testing, and release of autologous and allogeneic cell therapy products for clinical and commercial supply. Headquartered in Princeton, New Jersey, we combine deep scientific expertise with agile, client-focused execution to deliver reliable and scalable manufacturing solutions. Backed by GC Corporation, a global leader in the pharmaceutical and biotechnology industries, Made Scientific is committed to advancing innovative therapies that improve patient lives.

The Manager, Quality Engineering is a hands‑on role responsible for providing strategic direction, quality oversight and execution of validation activities for facilities, utilities, equipment, computerized systems, and manufacturing processes supporting cell therapy operations. This role ensures systems remain qualified/validated, and in a state of control throughout their lifecycle using phase appropriate GMPs.

• Provide validation support for GMP facilities, utilities, equipment, computerized systems, and manufacturing processes.
• Establish and maintain risk‑based Quality Engineering strategies, standards, procedures, and governance aligned with cGMP and regulatory requirements.
• Provide Quality oversight and approval of qualification and validation protocols, reports, change controls, deviations, CAPAs, and associated technical documentation.
• Partner with Engineering, Manufacturing, Validation, Quality, and other functions to assess and mitigate quality and compliance risks.
• Provide strategic validation input for facility expansions, equipment implementation, technology transfers, process changes, and other strategic projects.
• Ensure significant equipment, facility, and process‑related deviations are appropriately investigated, with effective root cause analysis and sustainable CAPAs.
• Establish lifecycle management strategies to ensure qualified/validated systems remain in a state of control.
• Identify trends, compliance gaps, and improvement opportunities through Quality Engineering metrics and risk assessments.
• Provide Quality Engineering leadership during regulatory inspections, client audits, qualification activities, and inspection readiness efforts.

• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline.
• 5 years of progressive Quality Engineering, Validation, Engineering, or Quality experience within biotechnology, pharmaceutical, or regulated manufacturing, including leadership experience.
• Strong knowledge of cGMP requirements, phase appropriate GMPs for validation, Quality Risk Management, qualification, validation, and lifecycle management principles.
• Demonstrated experience with facilities, utilities, equipment, process, and computerized system validation.
• Experience with deviations, CAPAs, change control, root cause analysis, and risk assessment.
• Experience supporting regulatory inspections and client audits.
• Strong leadership, communication, decision‑making, and cross‑functional collaboration skills.
• Demonstrated ability to lead complex initiatives and influence stakeholders across technical and Quality functions.

• Advanced degree in Engineering, Life Sciences, or related discipline.
• Experience in cell and gene therapy, biologics, or aseptic manufacturing.
• Experience supporting facility start‑up, expansion, technology transfer, multi sites, and commercialization.
• Experience with in a CDMO or multi‑client manufacturing environment.
• Knowledge of U.S., EU, and global regulatory expectations for qualification and validation.

• Work is…