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US Quality Assurance Head - GMP & Regulatory Leader
Job in
Pennington, Mercer County, New Jersey, 08534, USA
Listed on 2026-08-22
Listing for:
GenScript
Full Time
position Listed on 2026-08-22
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
GenScript USA Inc./Pro Bio 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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