SeniorSpecialist,ClientQA

**Senior 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 Senior Specialist, Client QA is responsible for providing QA 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. The Senior Specialist, Client QA serves as the dedicated Client QA Representative and liaisons with the Client and other functions including Project Management, Process Development, Technology Transfer, Manufacturing, Quality Control and other functions within the Quality Assurance unit. Responsibilities include tracking and reviewing technology transfer documents, specifications, master batch records, change requests, deviations and failure investigations supporting the release of manufactured material. The Senior Specialist, Client QA will report to the Manager, Client QA. **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 release timelines and deviation trends. * Collaborate with clients during initia