Head of US Quality Assurance

United Statesfull timeOn Site

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senior

$190k–$250k

H1B: yes

Genscript The Head of Quality Assurance leads the US Quality Assurance organization ensuring 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.

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.

Qualification

Bachelor's degree in Life SciencesStrong experience supporting biologicsExtensive knowledge of FDAExcellent leadership

Required

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