Definition, Global implementation and ongoing management of IT Systems Validation process for locations in North America. This includes GxP Compliance, CSV and SOX Compliance. Direct the worldwide IT Quality organization and manage staff, consultants and 3rd party vendors serving a user base spread across North America and Puerto Rico.Management of Global IT validation programs for 10+ global GxP applications (including Oracle R12, Trackwise, Veeva, eTQ Reliance, eTMF/CTMS, Veeva CDMS, ServiceNow and Infrastructure Qualification (IQ/OQ) for Cloud and hosted infrastructure .Direct the IT vendor qualification program for vendors providing services (SAAS, Data Center hosting, Infrastructure As a Service (IAAS), Platform As a service (PAAS) and Infrastructure supporting GxP applications and validation support services.Led the CSV validation effort for global business transformation program, enabling the consolidation of 27 legacy ERP systems into a single global architecture on Oracle’s business R12 for US and EMEA locations. Completed the validation and integration of Codman J&J Switzerland and Mansfield manufacturing sites including implementation and validation of OracleR12, QMS and site applications as part of global acquisition from J&J. Partner with business leadership teams in the development of strategic plans, funding, vendor selection and delivery of integrated solutions to enable global visions for Quality, Compliance, Research & Development and Clinical Affairs.Global IT Compliance Leader Responsible for budget and strategic planning with business and technology executives. Global Complaints Management process improvement and electronic submission to the agencies resulting in 57% reduction in MDR cycle, 100% reduction in shipping cost and 32% reduction in resources cost. Lead the remediation of audit items and trend analysis of audit issues to highlight root causes for driving compliance improvements.

Systems are in compliance with applicable regulations and are run as per defined policies, project management framework and procedures. It also includes definition and implementation of new and improvement and enhancement of existing policies and procedures. This was done by managing internal and external vendors and offshore and onsite resources.Led a startup IT Quality department from ground up to support growing needs of the business and transformed it into a cohesive and aligned Global compliance delivery organization. Established governance for Global CSV, SDLC and Change management processes including development of policies, templates and standards for the enterprise. Management of Global Change control process for enterprise GxP and site level applications to maintain the validated sate of the applications by leveraging validated tools and technology.Process and compliance management of Oracle 11.5.9 Global rollouts to Burlington, Ireland and San Diego facilities and Oracle 11.5.10 upgrade including UAT and System Testing.Development and implementation of procedures and work practices governing the Global Agile electronic documentation system to support document control and archival of GXP validation deliverables which was formerly manual, and paper based.•Responsible for evaluating and approving validation documentation Global IT systems.Advised the business groups on procedures and project management in a consultative role for implementations of Global GxP systems.Integration and Standardization of IT systems for acquired business.