US Quality Assurance Lead - Biotech CDMO

GenScript/ProBio; Pennington (NJ); On-site; USD 190,000 - 250,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

Paid parental leave

Paid time off

Job summary

GenScript USA Inc/ProBio Inc. seeks a Head of Quality Assurance to lead the US QA organization, ensuring FDA/EMA/ICH/GMP compliance across CDMO manufacturing.

You will oversee QMS, deviations, CAPA, change control, and product release activities to support client projects. The role requires 10+ years in biotech quality leadership, strong regulatory knowledge, and proven experience in inspections and customer audits, with a focus on building a high-performing team and driving continuous

Qualifications

• 10+ years of quality leadership experience in biotechnology, pharmaceutical, or CDMO environments.
• Experience with Quality Management Systems (QMS), Quality Operations, and Quality Risk Management.
• Strong experience supporting biologics, plasmid DNA, viral vectors, cell & gene therapy, or other GMP manufacturing operations.
• Extensive knowledge of FDA, EMA, ICH, and global GMP regulations.
• Proven experience leading regulatory inspections and customer audits.

Responsibilities

• Lead the US Quality Assurance organization and provide strategic leadership to ensure compliance with FDA, EMA, ICH, and GMP regulations.
• Develop, implement, and continuously improve the Quality Management System (QMS), including deviations, CAPA, change control, document control, quality risk management, and training compliance.
• Provide QA oversight for GMP manufacturing, process development, technology transfer, validation, qualification, batch record review, and product release activities.
• Ensure continuous regulatory compliance and maintain inspection readiness for FDA, customer, and other regulatory inspections and audits.
• Lead customer quality activities, including Quality Agreements, customer audits, quality investigations, and issue resolution.
• Partner with Manufacturing, Process Development, Engineering, Validation, Supply Chain, Project Management, and Commercial teams to ensure successful execution of CDMO projects while maintaining quality and compliance.
• Drive continuous improvement initiatives to strengthen quality systems, operational excellence, and organizational effectiveness.
• Develop, coach, and lead a high-performing Quality Assurance team by fostering talent development, succession planning, and a culture of quality and accountability.
• Monitor quality metrics, identify risks, and implement proactive actions to continuously improve quality performance and compliance.

Skills

QA Leadership

Quality Systems

Regulatory Compliance

Stakeholder Management

Biotech GMP operations

Education

Bachelor's degree in Life Sciences

Advanced degree (M.S./Ph.D.) preferred

Job description

GenScript USA Inc/ProBio Inc. seeks a Head of Quality Assurance to lead the US QA organization, ensuring FDA/EMA/ICH/GMP compliance across CDMO manufacturing.

You will oversee QMS, deviations, CAPA, change control, and product release activities to support client projects. The role requires 10+ years in biotech quality leadership, strong regulatory knowledge, and proven experience in inspections and customer audits, with a focus on building a high-performing team and driving continuous