Head of US Quality Assurance

BioSpace; 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-m

Paid parental leave

Paid time off (vacation, personal, and

Sick time and holidays

Flexible spending accounts

Health savings accounts

Life and AD&D insurance

Disability coverage

Legal assistance

Pet insurance

Critical illness coverage

Accident insurance

Hospital indemnity insurance

Commuter benefits

Well-being initiatives

Peer-to-peer recognition

Job summary

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

You will oversee QMS, deviations, CAPA, change control, and batch release while coordinating with Manufacturing, Process Development, Engineering, Validation, and Supply Chain to deliver quality projects. The role requires 10+ years of quality leadership in biotechnology/CDMO settings, strong knowledge of global regulations, and

Qualifications

• Bachelor's degree in Life Sciences, Biotechnology, Pharmacy, Chemistry or related field; MS/PhD preferred.
• 10+ years of progressive quality leadership experience in biotechnology, pharmaceutical, or CDMO environments.
• Strong experience with Quality Management Systems (QMS), Quality Operations, and Quality Risk Management.
• Extensive knowledge of FDA, EMA, ICH, and global GMP regulations.
• Proven experience leading regulatory inspections and customer audits.
• Experience supporting biologics, plasmid DNA, viral vectors, cell & gene therapy, or GMP manufacturing operations.

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

Quality leadership

QMS

Regulatory inspections

Cross-functional leadership

GMP knowledge

Biotech/CDMO experience

Quality risk management

Education

Bachelor's degree in Life Sciences

Advanced degree preferred

Job description

About GenScript

Founded in 2002 in New Jersey, GenScript Biotech Corporation accelerates innovation in biotech and healthcare by providing researchers and companies with the building blocks needed to develop groundbreaking treatments and products. Guided by its mission to Make People and Nature Healthier Through Biotechnology, and its role as a well-recognized biotechnology company, GenScript has a team of approximately 6,165 employees and has served more than 200,000 customers across over 100 countries and regions.

About ProBio

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

Benefits

• medical, dental, and vision insurance
• 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
• supplemental plans such as critical illness
• supplemental plans such as accident
• supplemental plans such as hospital indemnity insurance
• commuter benefits
• well-being initiatives
• peer-to-peer recognition programs

GenScript USA Inc/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.

GenScript USA Inc./ProBio Inc. maintains a drug-freeworkplace.

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