Job Description
Sr. Manager, Quality
Position Summary:
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 Sr. Manager, Quality is responsible for providing end-to-end Quality Assurance (QA) and Quality Control (QC) oversight for the BWI2 plasmid DNA (pDNA) manufacturing facility. This role ensures that all operations meet GMP requirements, internal quality standards, and regulatory expectations (FDA, EMA, ICH, and applicable pharmacopeias).
As the facil...