Senior Manager, Product Development Quality Assurance (CMC Product Lead)

Primarily responsible for ensuring the timely release of GMP clinical supplies by providing direction and quality oversight of the supply chain including, manufacturing, testing and release processes from drug substance to drug product to finished product. As a team member in interdisciplinary product development teams (e.g., CMC teams), the Senior Manager is responsible for early identification and prevention of pipeline risks by driving consensus-building across AbbVie R&D functions and external partners. Responsibilities include being the QA representative for CMC product development teams to facilitate the approval of drug to clinical trials according to program timelines. Provide program oversight for the RDQA QA organization; includes timely communications on program strategies, issue and risk management. Lead complex global cross-functional process improvement teams and provide innovative and risk-based solutions to complex technical problems.