Key responsibilities are performing GMP tasks/activities associated with maintaining compliant Quality Control and Stability laboratories; analyzing, interpreting, and trending results/data; creating, reviewing, executing activates for, and approving documentation; participating in and/or leading investigations of events/OOS results; designing, organizing, and/or conducting assay development/automation/troubleshooting/method transfer/validation activities, acting as a change agent and driving continuous improvement/Operational Excellence/innovative implementations; represents and makes decisions for Quality Control on cross functional teams; leads projects and/or teams providing guidance/training/coaching to junior colleagues; and conducting project management for site and network projects. Individual should have knowledge and be technically competent of US, EU, and ROW cGMP; pharmacopeias; ICH guidelines; analytical techniques and instrumentation, Laboratory Information Management System (LIMS); Global Quality Tracking System (TrackWiseTM application); Microsoft Office applications specifically Word, Excel, and PowerPoint; statistical software such as JMPTM and MinitabTM; Lean Six Sigma concepts; Lean Labs; project management tools including stakeholder management; formal Quality Change Control, Investigations, and Documentation systems, and Quality Risk Management including risk assessments.