Head of US Quality Assurance

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.

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.

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 have

Advanced degree (M.S. or Ph.D.) preferred

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 three months of employment; paid time off including 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, critical illness, accident, and hospital indemnity insurance; commuter benefits; well-being initiatives; peer-to-peer recognition programs