This position will work cross functionally with quality assurance operations, quality control, manufacturing, validation, Manufacturing Science &Technology (MS&T), and external vendors to gather, analyze and interpret and report data from product manufacturing and testing as part of trending programs (e.g., Product Quality Review, Quality Event Trending, clinical manufacturing in process and release/ stability data, laboratory controls data) to address adverse trends/ gaps as part of continuous improvement. Responsibilities & Duties: Compliance Management: Responsible for tracking, management, and completion of cross functional areas Quality Records (such as deviations, lab investigations, change control, complaints, and CAPA) in partnership with applicable SMEs and leads error prevention and continuous improvement initiatives based on identified recurring root cause.