Manager Quality Assurance - Night Shift

In this vital role you will be the Manager Quality Assurance for the PQA team and will work directly with plant manufacturing and engineering staff during the Amgen North Carolina (ANC) facility startup and transition to on-going bulk drug substance manufacturing, including development, clinical, launch and commercial operations. The Manager Quality Assurance will hire, train, develop, and manage Quality Assurance professionals to successfully deliver on role to support (Good Manufacturing Practices) GMP Manufacturing and to oversee and manage change in an effective, efficient and compliant manner. This includes partnership with Manufacturing, Facilities & Engineering and other support functions providing coaching, guidance and direction in regards to deviations, quality systems and compliance aspects. The initial focus of this role will be on the ANC startup to prepare the new facility for Operational Readiness. *Candidate will be working on site. After the facility startup phase, the successful incumbent will be expected to transition to a shift working schedule, to include late afternoon and nights.