- Led the Global Quality Governance Team responsible for: o The oversight, analysis, automation and on time delivery of key quality and performance metrics o Global / Local Clinical Development Regulatory Inspections Oversight & Tracking o Global / Local Incident Triage, Management Escalation and Tracking o Managing and Chairing the GCP/PV Regulatory Inspections Governance Board o Inspection, Audit and Quality Issue Oversight and Tracking, including associated CAPA’s o Managing and tracking Quality Plan deliverables - Led global quality process improvement initiatives, partnering with numerous leaders and functional stakeholders to drive success - Supervised and mentored the Global Quality Governance Team, providing coaching, performance management and driving individual development - Designed, implemented, & managed oversight of key quality and performance metrics to support predictive analytics and risk identification. - Lead Author / Core Contributor for multiple cross functional SOPs, business practices and guidelines, facilitated alignment with all impacted functions & stakeholders. - Designed and implemented global, cross functional, role-based training to support Process & System improvement initiatives - Redesigned the system and end user support models for Audit and Compliance Computerized Tracking systems o Designed end user training programs and reference materials o Conducted numerous, Global, Instructor led End User and Super User training sessions o Collaborated with IT to implement changes to the technology platforms to further support process improvements and improve data analytics. - Mobilized a global, cross functional team to facilitate design input into a new unified Audit, Compliance & Third Party Management Computerized Tracking system o Facilitated input from 58+ stakeholders from 19+ different business units into various stages of system development

- Executed global vendor and process quality assurance audits across multiple disciplines and within a multi-cultural environment o Audit Expertise includes; Clinical, Data Management / Biostatistics, Computerized Systems Validation, Service Providers, Internal Process Audits, Clinical Pharmacology Units, Bio-Imaging, Investigator Sites, and Due Diligence Assessments o Experience working and auditing in North America, Latin America, Asia-Pacific, Australia and Europe - Developed and implemented a competency-based training and certification scheme for the global auditing group o Authored the overall processes & certification criteria o Authored Training Modules for Audits conducted at; Sponsor Affiliates, Central Laboratories, Clinical Phase One Units, Contract Research Organizations, Computerized System Validation, Investigator Sites, Data Management, Independent Reading Facilities, Pharmacovigilance o Authored Additional training curricula for Lead Auditors, Mentors, Inspections Management & Due Diligence activities - Identified areas of innovation and managed quality issues and process improvement in support of stakeholders - Authored global, cross functional SOPs - Mentored and prepared investigational sites for regulatory authority inspections - Led the development and implementation of two computerized Audit Management Systems

- Defined the quality oversight program for assigned clinical trials - Executed global clinical quality assurance audits across multiple disciplines - Mentored Junior QA Auditors - Conducted company-wide training on GCP, computerized systems validation requirements, HIPAA compliance, ISO 9001:2000 standard, regulatory inspection procedures - Managed sponsor audits

- Conducted study initiation, monitoring, data management and closure visits at investigational sites across multiple therapeutic areas - Planned, supervised and assisted in FDA compliance Inspections, as well as sponsor and data audits