LeadQASpecialist-ClientQA

**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 Client QA Representative, you’ll oversee projects from start to finish—partnering with cross-functional teams in Manufacturing, Process Development, Technology Transfer, and Quality Control. Your work will include reviewing and tracking critical GMP documentation such as technology transfer records, specifications, master batch records, and investigations, all supporting the release of life-changing therapies. This is an opportunity to make a direct impact on patient health while collaborating in a dynamic, growth-driven environment. **The Role** * Provide dedicated QA support for client projects and client interactions, serving as the primary QA contact throughout the project lifecycle. * Provides quality oversight of GMP operations for the manufacture of master/working cell banks, bulk drug substance and/or final drug product * Support clinical and commercial QA activities from process development through non-clinical and commercial production. * Track and present key quality metrics for client projects, including batch rel