The Quality Assurance (QA) Representative will provide quality oversight and compliance support for Clinical Development and Pharmacovigilance (PV) activities related to biologic development programs. This individual will be responsible for ensuring that clinical trial execution, safety reporting, and pharmacovigilance systems meet Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) requirements, as well as all applicable global regulatory standards.
As a Benefits Quality Assurance Analyst, you will be responsible for overseeing the core operations, processes, and quality standards of the benefits plan build and maintenance to ensure the delivery of a high quality SmithRx product. Communicate project status and escalate issues for improved workflow efficiency. Collaborate with engineers on system enhancements to create workflow automation.
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, 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.