Director of Quality Engineering, Cell Therapy

ADP, Inc.; Princeton (NJ); On-site; USD 150,000 - 190,000; Full time

Job summary

Made Scientific, a leading US-based cell therapy CDMO, seeks a Director of Quality Engineering to provide strategic direction and QA oversight for facilities, utilities, equipment, and computerized systems supporting cell therapy operations. You will lead QA activities to keep systems qualified, validated, compliant, and in a state of control throughout their lifecycle.

The role requires 10–12 years of progressive QA experience, strong leadership, and the ability to influence across technical

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related discipline.
• 10–12 years of progressive Quality Engineering, Validation, Engineering, or Quality experience with leadership.
• Strong knowledge of cGMP, Quality Risk Management, qualification, validation, and lifecycle management.
• Experience with deviations, CAPAs, change control, root cause analysis, and risk assessment.
• Experience supporting regulatory inspections and client audits.

Responsibilities

• Lead the Quality Engineering function for GMP facilities, utilities, equipment, computerized systems, and manufacturing processes.
• Establish and maintain risk-based Quality Engineering strategies aligned with cGMP and regulatory requirements.
• Provide oversight and approval of qualification/validation protocols, reports, change controls, deviations, CAPAs, and documentation.
• Partner with Engineering, Manufacturing, Validation, Quality to mitigate quality and compliance risks.
• Provide Quality leadership for facility expansions, equipment implementation, tech transfers, process changes, and strategic projects.
• Ensure investigations of deviations with root cause analysis and sustainable CAPAs.
• Develop lifecycle management strategies to keep systems in a state of control.
• Identify trends and improvement opportunities through Quality Engineering metrics and risk assessments.

Skills

Leadership

Communication

Decision making

Cross-functional collaboration

Quality systems

Education

Bachelor’s degree in Engineering/Life Sciences

Advanced degree preferred

Job description

Made Scientific, a leading US-based cell therapy CDMO, seeks a Director of Quality Engineering to provide strategic direction and QA oversight for facilities, utilities, equipment, and computerized systems supporting cell therapy operations. You will lead QA activities to keep systems qualified, validated, compliant, and in a state of control throughout their lifecycle.

The role requires 10–12 years of progressive QA experience, strong leadership, and the ability to influence across technical