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. 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. Provide innovative and risk-based solutions to complex technical problems. Support the preparation of regulatory inspections and internal audits and represent Quality in inspections and audits. Write/ review/ approve exception reports, including high impact and complex investigations impacting multi-functional areas. Provide management of clinical supply product actions and stock recovery. Conduct the onboarding of new assets. Perform due diligence of potential assets. Ensure suitable quality agreements or quality aspects of contracts are in place between R&D and third-party manufacturers, third party laboratories, and other service providers. Interact with and influence decision making at the senior leadership level as well as with external customers. This role can be remote within the US.