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Head of Quality Assurance (QA) at GenScript - ApplyBlast

Head of Quality Assurance (QA)

GenScript

2 months ago

2.4 on Glassdoor

Pennington, New Jersey, United States

Onsite

Full Time

Director

0 applicants

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About this role

The Head of Quality Assurance leads the US QA organization for ProBio, ensuring compliance with FDA, EMA, ICH, and GMP regulations across all CDMO manufacturing operations. This senior role oversees quality systems, regulatory compliance, inspection readiness, and collaborates with cross‑functional teams to support business growth and project delivery.

Responsibilities

Lead the US Quality Assurance organization and ensure regulatory compliance
Develop, implement, and continuously improve the Quality Management System
Maintain inspection readiness and oversee GMP manufacturing oversight

Skills

Qualifications

Bachelor's degree in Life Sciences, Biotechnology, Pharmacy, Chemistry or related fieldM.S. (Master of Science)Ph.D. (Doctorate)

About GenScript

genscript.com

Headquarters

Piscataway, New Jersey, United States

Company Size

5001-10000 employees

Founded

2002

View Profile

GenScript is a global biotechnology company that supplies synthetic genes, peptides, proteins, antibodies and a broad catalog of life-science reagents and assay tools. It also provides custom services across discovery and development—gene synthesis, peptide/protein production, antibody discovery and engineering, CRISPR genome‑editing reagents, cell‑line development, and biologics CDMO capabilities. Academic labs, biotech and pharma customers rely on GenScript for scalable, quality‑controlled reagents and end‑to‑end contract services with rapid turnaround and online ordering.