Director, Quality Engineering

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

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Director, Quality Engineering

Manager Princeton, NJ, US

2 days ago Requisition ID: 1010

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 QualificationsAdvanced 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.
• Work is performed in a combination of manufacturing, laboratory, warehouse, mechanical, and office environments.
• May work around manufacturing equipment, mechanical systems, chemicals, and hazardous materials.
• Required to wear appropriate personal protective equipment (PPE) and follow applicable safety and GMP requirements.
• May require occasional work outside of normal business hours to support maintenance needs or facility emergencies.
• Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions of the position.

Equal Employment Opportunity Statement

Made Scientific is proud to be an Equal Opportunity Employer committed to fostering a diverse and inclusive workplace. We make employment decisions based on qualifications, merit, business needs, and job requirements without regard to race, color, religion, creed, sex, pregnancy, childbirth or related medical conditions, sexual orientation, gender identity or expression, national origin, ancestry, age, disability, genetic information, marital status, military or veteran status, citizenship status, or any other status protected by applicable federal, state, or local law.

Made Scientific is committed to providing reasonable accommodations to qualified individuals with disabilities and to applicants and employees with sincerely held religious beliefs, practices, or observances, unless doing so would create an undue hardship.