US Quality Assurance Head - GMP & Regulatory Leader

Posted 2 days ago

genscriptPennington (NJ)

Quality Control Systems Managers Research and Development in Biotechnology (except Nanobiotechnology)

SENIORITY

Manager

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About the role

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 across all CDMO manufacturing operations. The role collaborates with cross‑functional teams to support growth and successful customer project delivery. Responsibilities include developing and maintaining the QMS, managing deviations, CAPA, change control, document control, and product release oversight, while preparing for regulatory inspections

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