Sioux Falls, SD26 days ago
The VP QC partners closely with Technical Operations/CMC, Quality Assurance, Regulatory Affairs, IT and other cross‑functional teams to enable effective technology transfer, analytical method lifecycle management, and product release testing strategies for plasma‑derived antibody products. Lead the development and execution of a global commercial analytical assay reduction strategy, ensuring alignment with FDA CBER expectations for risk‑based, lifecycle‑managed control strategies and EMA and MHRA requirements for comparability, post‑approval change management, and variation classification, while maintaining compliance, inspection readiness, and uninterrupted commercial supply.