Head of US Quality Assurance
About The Position
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. 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.
Requirements
- Bachelor's degree in Life Sciences, Biotechnology, Pharmacy, Chemistry, or a related scientific discipline.
- 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.
Nice To Haves
- Advanced degree (M.S. or Ph.D.) preferred.
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.
Benefits
- Medical insurance
- Dental insurance
- 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 accounts
- Health savings accounts
- Life and AD&D insurance
- Short-term disability coverage
- Long-term disability coverage
- Legal assistance
- Supplemental plans such as pet insurance, critical illness insurance, accident insurance, and hospital indemnity insurance
- Commuter benefits
- Well-being initiatives
- Peer-to-peer recognition programs
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What This Job Offers
Job Type
Full-time
Career Level
Senior
