Director, Quality Engineering

Job Description

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. 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 Director, Quality Engineering is a hands-on leadership role responsible for providing strategic direction and Quality oversight of facilities, utilities, equipment, computerized systems, and manufacturing processes supporting cell therapy operations. This role leads Quality Engineering activities to ensure systems remain qualified, validated, compliant, and in a state of control throughout their lifecycle.

Key Responsibilities

• Lead the Quality Engineering function and provide Quality oversight 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 Quality leadership 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 validated and qualified 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.
• Lead, coach, and develop Quality Engineering team members while fostering accountability, collaboration, and continuous improvement.

Required Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline.
• 10–12 years of progressive Quality Engineering, Validation, Engineering, or Quality experience within biotechnology, pharmaceutical, or regulated manufacturing, including leadership experience.
• Strong knowledge of cGMP requirements, Quality Risk Management, qualification, validation, and lifecycle management principles.
• Demonstrated experience with facilities, utilities, equipment, process, and computerized system qualification and 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.

• Preferred Qualifications 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, and commercialization.
• Experience within a CDMO or multi-client manufacturing environment.
• Knowledge of U.S., EU, and global regulatory expectations for qualification and validation.