CMC Quality Manager, Analytical

The CMC Quality Manager, Analytical, provides quality oversight and technical leadership for analytical development and testing activities supporting veterinary pharmaceutical products under FDA Center for Veterinary Medicine (CVM) guidance. This role ensures that analytical methods, stability programs, and product testing are scientifically sound, validated, and compliant with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and applicable regulatory expectations. Daily work includes providing quality oversight for analytical method development, qualification, validation, and transfer in support of veterinary drug substance and drug product programs. Responsibilities include reviewing and approving analytical study protocols, validation reports, method transfer packages, and specifications, as well as ensuring analytical testing, release, and stability studies are executed under GMP/GLP conditions and in compliance with FDA and ICH/VICH guidelines. The role also involves regulatory and compliance responsibilities such as ensuring analytical activities comply with FDA-CVM, ICH, and VICH quality and data integrity requirements, providing quality input for analytical sections of CMC documentation, and supporting internal and external audits of analytical laboratories.