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.
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
# 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.
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.
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.
Skills Required
- Bachelor's degree in Life Sciences, Biotechnology, Pharmacy, Chemistry, or related discipline
- Advanced degree (M.S. or Ph.D.) in relevant field
- 10+ years progressive Quality leadership experience in biotechnology, pharmaceutical, or CDMO environments
- Demonstrated experience with Quality Management Systems (QMS), deviations, CAPA, change control, document control, and training compliance
- Experience in Quality Operations and Quality Risk Management
- Strong experience supporting biologics, plasmid DNA, viral vectors, cell and 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, and maintaining inspection readiness
- Experience providing QA oversight for manufacturing, process development, technology transfer, validation, qualification, batch record review, and product release
- Leadership, communication, strategic thinking, stakeholder management, and ability to drive continuous improvement
GenScript Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about GenScript and has not been reviewed or approved by GenScript.
-
Healthcare Strength — Feedback suggests medical coverage is solid, with mentions of comprehensive health plans and employer HSA support in some options. Company communications also emphasize robust health benefits alongside wellbeing and training initiatives.
-
Leave & Time Off Breadth — Feedback suggests a range of paid time off types, including vacation, sick time, company holidays, and additional leave categories. Some roles reference flexible vacation arrangements that broaden usable time off.
-
Retirement Support — Feedback suggests retirement offerings include a 401(k) with company match in certain postings. This provides a longer-term savings component within total rewards.
GenScript Insights
What We Do
Founded in 2002 and listed on the Hong Kong Stock Exchange in 2015, GenScript has an established global presence across Greater China, North America, the EU, and Asia Pacific. Today, over 300,000 customers from over 160 countries and regions worldwide have used GenScript’s premier, convenient, and reliable products and services. GenScript currently has over 5,000 employees globally, 33% holding master’s and/or Ph.D. degrees. In addition, GenScript has a number of leading commercial technologies developed in the fields of synthetic biology, immunotherapy, antibody design, chemical synthesis, and bioinformatics, including more than 100 patents and over 270 patent applications. As of June 2022, GenScript's products and services have been cited by 74,700 scientific papers worldwide. GenScript is committed to striving toward its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology.
