This position’s primary role is to provide on-site (person in plant) Quality Operations and compliance management for a drug substance contract manufacturing organization (CMO) located in Frankfurt, Germany. Responsibilities include managing manufacturing and disposition activities as well as deviations, CAPA, and change controls. The successful candidate will ensure the CMO meets internal Alnylam and health authority expectations regarding the cGMP manufacturing. The candidate will contribute to team based collaborative environment promoting commitment to continuous improvement and achievement of goals.
In addition, the candidate will be required to provide occasional support to other Alnylam CMOs in Germany and Switzerland that provide raw materials, drug product and finished goods.
This position will be principally located in Amsterdam, Netherlands with frequent travel to the drug substance CMO in Frankfurt, Germany. This position reports to the Associate Director, QA in Zug, Switzerland.