North Carolina13 days ago
Provide Quality oversight and lifecycle management of the global stability program, including protocol design input and approval, execution oversight, data review and interpretation, trend analysis, and reporting while ensuring that stability studies support regulatory filings, shelf‑life assignments, and ongoing product verification. Provide quality oversight and approval of Laboratory Investigations, (including OOS, OOT, atypical results, deviations, and data integrity events), ensuring investigations are scientifically sound, risk‑based, appropriately escalated, trended for systemic issues, and supported by effective CAPAs through closure.