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US Quality Assurance Lead - Biotech CDMO
Job in
Pennington, Mercer County, New Jersey, 08534, USA
Listed on 2026-08-22
Listing for:
GenScript/ProBio
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. seeks a Head of Quality Assurance to lead the US QA organization, ensuring FDA/EMA/ICH/GMP compliance across CDMO manufacturing.
You will oversee QMS, deviations, CAPA, change control, and product release activities to support client projects. The role requires 10+ years in biotech quality leadership, strong regulatory knowledge, and proven experience in inspections and customer audits, with a focus on building a high-performing team and driving continuous
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