Lead, Quality Assurance, GDP

Purpose and Scope:

Summarize the primary purpose of the position in 1-3 sentences. Intent is to capture the work this position does and is accountable for and why the role exists as a unique position. Not intended to be a summary of all duties.

This position is responsible for US Good Distribution Practice (GDP) QA oversight of Storage and Distribution activities related to commercial products. Oversees and defines quality expectations and provides support to the Supply Chain Management (SCM) group and external Third-Party Logistics (3PL) providers to ensure effective quality systems that meet Good Manufacturing Practice (GMP), GDP, and Astellas requirements for upstream supply chain related activities (Plant/Contract Manufacturing Organization-to-3PL or 3PL-to-Astellas affiliate).