Head of Quality Engineering, Cell Therapy

Made Scientific; Princeton (NJ); On-site; USD 180,000 - 240,000; Full time

Job summary

Made Scientific is seeking a Director of Quality Engineering in New Jersey to provide hands-on leadership and strategic quality oversight of facilities, utilities, equipment, and computerized systems supporting cell therapy operations. The role ensures systems remain qualified, validated, compliant, and in control throughout their lifecycle.

The Director will lead cross-functional teams, drive risk-based strategies, and partner with Engineering, Manufacturing, Validation, and Quality to advance

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or 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.
• Preferred advanced degree in Engineering, Life Sciences, or related discipline.
• Experience in CDMO or multi-client manufacturing environments is a plus.

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.

Skills

Quality Engineering

Validation

cGMP

Leadership

Cross-functional collaboration

Risk assessment

Regulatory inspections

Project leadership

Education

Bachelor’s degree in Engineering or Life Sciences

Advanced degree preferred

Job description

Made Scientific is seeking a Director of Quality Engineering in New Jersey to provide hands-on leadership and strategic quality oversight of facilities, utilities, equipment, and computerized systems supporting cell therapy operations. The role ensures systems remain qualified, validated, compliant, and in control throughout their lifecycle.

The Director will lead cross-functional teams, drive risk-based strategies, and partner with Engineering, Manufacturing, Validation, and Quality to advance