Novartis country quality providing QA guidance to US Business Partners (Clinical, Medical, PV, Legal etc) . Core member of Process Training Governance Board reviewing all Novartis processes and roles. Represent QA to external Health Authorities and internal partners. Ensure readiness for GCP and GPvP inspections, provide inspection management, CAPA support to US and global business partners. Responsible for identification of gaps, risk assessment, risk mitigation planning and execution for Business Units. In collaboration with Business Units develop the US Quality Plan, drive implementation of Global Quality Documents. Quality Vendor oversight through KPI deliverables, CAPA management. Develop and report Key Quality Metrics for internal business units, key line functions.

Oversee clinical trial operations and data management for global development programs for clinical drug device combination. Oversee all clinical trial activities - trial execution, plan study logistics i.e. country participation, HA requirements, supply and delivery logistics. Assist in submission to HAand prepare inquiry responses. Interact with KOL's regarding study conduct, participate in steering committee meetings. Manage multiple vendors building relationships and ensuring deliverables. Conduct Governance Meetings with all vendors. Prepare and report monthly KPI metrics for multiple programs.

Oversee clinical trial operations and medical imaging lab. Strategic planning and execution of clinical trial programs from development to publication. As member of Sr. Leadership team responsible for reporting clinical trial metrics, budget, resourcing and outsourcing needs monthly. Instituted revised process for several aspects of the clinical trial process: EDC, electronic TMF document management for clinical trials and imaging lab improving quality and increasing efficiencies. Vendor management and oversight through KPI deliverables. Participate in Health Authority meetings and provide clinical responses. Managed a large team of global clinical research professionals, responsible for performance management, mentoring and coaching.

Oversee US Clinical Operations ensuring clinical trial deliverables on time and on budget. Responsible for budget, resourcing and outsourcing needs through a 5 year plan for multiple therapeutic areas. Oversee clinical trial operations for clinical trials, IIT's, Managed Access Programs, HEOR , digital development program. Vendor management, contract review and negotiations, KPI's. Developed preferred partnership with CRO's building strong collaboration to ensure on time deliverables. Manage a large team of clinical research professionals, performance management, coaching.