The position transitions from initial site startup strategy—focusing on SOP lifecycle, risk management, MES batch records, and operational and regulatory readiness—to post go-live leadership over deviation management, RCA, change controls, continuous improvement, metrics governance, and team development. You have a demonstrated ability to lead effectively cross-functional and multi-disciplinary teams, and collaborate with colleagues across different functional departments (Operations, Engineering, QA, Supply Chain, Safety, etc.) to enable collective progress across the organization.