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Lead QA Specialist - Client QA

Catalent
Location 📍 Harmans, United States
Posted 📅 June 02, 2026
Work Type ⏰ Full-time

Position Overview

**Lead Specialist, Client QA**

**Position Summary:**

+ **Work Schedule: Monday – Friday, 8am – 5pm.**
+ **100% on-site**

Catalent is a leading global CDMO partnering with pharma and biotech innovators to accelerate development and delivery of life-changing therapies. Our FDA-licensed, state-of-the-art CGMP gene therapy campus in Harmans, MD—just minutes from BWI Airport—features EMA and FDA-approved manufacturing suites, fill/finish capabilities, labs, and warehousing to support Phase 3 through commercial production of advanced therapies, including AAV and other viral vector-based products.

The Lead Specialist, QA is responsible for providing QA lead support and oversight of Client Projects from start to finish for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product. You’ll play a key role in ensuring the quality and compliance of cutting-edge gene therapy products. Acting as the dedicated Cl...

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Job Details

Employment Type
Full-time
📊
Category
other-general
🏠
Work Arrangement
On-site
📍
Location
Harmans, United States