Head of US Quality Assurance

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

Benefits offered by this job

401(k) with company match

Paid parental leave

Flexible spending accounts

Job summary

GenScript USA Inc/ProBio Inc. is seeking a Head of Quality Assurance to lead the US QA organization and ensure compliance with FDA, EMA, ICH, and GMP regulations. You will drive QMS improvements, oversight of GMP manufacturing, and support cross-functional CDMO projects.

The role requires 10+ years in biotech/pharma QA leadership, strong leadership and stakeholder management, and proven experience with regulatory inspections and audits.

Qualifications

• Bachelor's degree in Life Sciences, Biotechnology, Pharmacy, Chemistry, or related field.
• Advanced degree (M.S. or Ph.D.) preferred.
• 10+ years of progressive Quality leadership experience in biotech/pharma/CDMO.

Responsibilities

• Lead US QA organization and ensure compliance with FDA, EMA, ICH, and GMP regulations.
• Develop and improve QMS including deviations, CAPA, change control, document control, risk management, training.
• Provide QA oversight for GMP manufacturing, tech transfer, validation, and batch release activities.
• Maintain inspection readiness for FDA, customers, and regulatory inspections/audits.
• Lead customer quality activities including Quality Agreements and audits.
• Collaborate with Manufacturing, Process Development, Engineering, Validation, Supply Chain, PM, and Commercial teams for CDMO projects.
• Drive continuous improvement to strengthen quality systems and organizational effectiveness.
• Coach and develop a high-performing QA team with a culture of quality.

Skills

Leadership

Regulatory compliance

Quality management

GMP knowledge

FDA inspections

Cross-functional collaboration

Strategic thinking

Education

Bachelor's in Life Sciences

MS/PhD preferred

Tools

QMS software

Document control systems

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.

Estimated Pay Range

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

Benefits

• Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one.
• We offer paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and company holidays.
• Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance.
• We also provide 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.

Equal Employment Opportunity

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-free workplace.