Senior Director, GCP Quality

About the role

General Summary: The Sr. Director, GCP Operational Quality will advance and provide strategic direction and oversight of the strategies, mechanisms, processes and capabilities for effective and proactive quality risk management across respective product/therapeutic program area(s) (e.g.; Cystic Fibrosis). This individual will serve as the GCP Operational Quality Lead and have overall responsibility for lifecycle review of risks to quality through ensuring appropriate oversight, mitigation strategies and plans enabling clinical quality outcomes and real time inspection readiness. This individual will provide strategic oversight and leadership for Quality Management Reviews, ensuring transparency for gaining insights regarding effectiveness of risk mitigation strategies/controls, proactive and sustainable clinical quality, and compliance for assigned programs. This individual will integrate end-to-end quality principles and review preparedness at key milestones