Head of US Quality Assurance

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, a subsidiary of GenScript, is a global CDMO offering end-to-end services from discovery to GMP for plasmids, antibodies, and cell & gene therapies. We bring together multidisciplinary expertise to accelerate development and manufacturing through customized, and comprehensive services. ProBio has established companies in the United States, the Netherlands, South Korea, and China (Hong Kong, Shanghai, and Nanjing) and other regions to serve global customers, and has helped customers in the United States, Europe, Asia Pacific and other regions obtain more than 150 IND approvals since October 2017.

Job Scope:

The Head of Quality Assurance (QA) is responsible for leading the US Quality Assurance organization to ensure compliance with FDA, EMA, ICH, and GMP regulations. This role oversees Quality Systems, GMP Quality Assurance, regulatory compliance, inspection readiness, and quality oversight across all CDMO manufacturing operations while partnering closely with cross-functional teams to support business growth and successful customer project delivery.

Key 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.

Qualifications:

• Bachelor's degree in Life Sciences, Biotechnology, Pharmacy, Chemistry, or a related scientific discipline. Advanced degree (M.S. or Ph.D.) preferred.
• 10+ years of progressive Quality leadership experience in biotechnology, pharmaceutical, or CDMO environments.
• Demonstrated experience in 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.
• Excellent leadership, communication, strategic thinking, and stakeholder management skills with the ability to influence cross-functional teams and drive continuous improvement.

The estimated pay range for the role is between $190K - $250K depending on experience and skill set

# LW

• medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one.
• paid parental leave after just three (3) months of employment,
• paid time off policy that includes vacation time, personal time, sick time, floating holidays, and company holidays.
• flexible spending and health savings accounts
• life and AD&D insurance
• short- and long-term disability coverage
• legal assistance
• supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance.
• commuter benefits, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

ProBio Inc. maintains a drug-free workplace.

Please note: ProBio Inc. will only contact candidates through verified application sources. Probio does not request personal information from candidates through individual email or any other platform.