- Performs Drug Product batch disposition activities upon review of executed batch records and certificate of analysis for commercial products
- Provides quality oversight for root-cause analysis and product impact assessment for investigations as a result of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified
- Facilitates continuous improvement efforts to improve CMO batch release metrics as needed
- Collaborates cross-functionally to integrate activities with other groups, departments and project teams as needed
- Models Vertex Core Values and leadership behaviors and fosters their demonstration in others
- Experience with commercial batch release activities, with proficient knowledge of the following in a pharmaceutical setting:
- cGMP's and associated CMC regulatory considerations
- Experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA
- Experience with network based applications such as Oracle and Trackwise preferred.
- M.S (or equivalent degree) and 0-3 years of relevant work experience, or
- B.S in scientific or allied health field (or equivalent degree) and 3-6 years of relevant work experience
Sthree US is acting as an Employment Business in relation to this vacancy.