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Senior US QA Leader: GMP, Regulatory Strategy, Compliance
Job in
Pennington, Mercer County, New Jersey, 08534, USA
Listed on 2026-08-24
Listing for:
BioSpace
Full Time
position Listed on 2026-08-24
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
GenScript USA Inc/Pro Bio Inc. seeks a Head of Quality Assurance to lead the US QA organization, ensuring compliance with FDA, EMA, ICH, and GMP across CDMO operations.
You will oversee QMS, deviations, CAPA, change control, and batch release while coordinating with Manufacturing, Process Development, Engineering, Validation, and Supply Chain to deliver quality projects. The role requires 10+ years of quality leadership in biotechnology/CDMO settings, strong knowledge of global regulations, and
#J-18808-LjbffrPosition Requirements
10+ Years
work experience
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