US Quality Assurance Lead — Biotech CDMO Excellence

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

Benefits offered by this job

Medical, dental, and vision insurance

401(k) retirement plan with company 1:

Parental leave

Paid time off

FSAs/HSAs

Life and AD&D insurance

Short- and long-term disability

Legal assistance

Pet insurance

Commuter benefits

Well-being programs

Peer recognition programs

Job summary

ProBio is seeking a Head of Quality Assurance to lead the US QA organization, ensuring FDA/EMA/ICH/GMP compliance across CDMO operations. You will drive QMS, deviations, CAPA, and change control while partnering with cross-functional teams to support growth and successful customer projects.

The role requires 10+ years of quality leadership in biotech/CDMO settings, strong regulatory inspection experience, and a track record of building high-performing teams.

Qualifications

• Bachelor's degree in Life Sciences, Biotechnology, Pharmacy, Chemistry or related scientific field; MS/PhD preferred.
• 10+ years of progressive Quality leadership experience in biotech or CDMO environments.
• Demonstrated experience in 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.
• Excellent leadership, communication, and stakeholder management skills.

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, and quality risk management.
• 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

Leadership

Regulatory knowledge

Quality management

Cross-functional leadership

Stakeholder management

Education

Bachelor's degree Life Sciences

MS/PhD preferred

Tools

QMS software

Deviation tracking tools

CAPA system

Change control software

Job description

ProBio is seeking a Head of Quality Assurance to lead the US QA organization, ensuring FDA/EMA/ICH/GMP compliance across CDMO operations. You will drive QMS, deviations, CAPA, and change control while partnering with cross-functional teams to support growth and successful customer projects.

The role requires 10+ years of quality leadership in biotech/CDMO settings, strong regulatory inspection experience, and a track record of building high-performing teams.