Nancy Sutter Email & Phone Number

Beijing, Cn

• Perform computer software validation/qualification activities including developing and executing software SDLC (Software Development Life Cycle) documentation. Actively perform or support all GLP/GMP computerized software and automated equipment validation in a compliant state.• Collaborate with system and equipment owners and actively manage validation documentation creation and development.• Manage vendor validation documentation.• Provide compliance guidance for GxP software updates and releases.• Monitor processes for adherence to established procedures/regulatory compliance.• Provide technical expertise, interpretation and direction to management and user departments to assure compliance with regulatory requirements, company policies and standards.

Tokyo, Jp, Jp

Developed and deployed risk-based validated implementations for enterprise quality systems. Adhered to Shire’s standards so each system was released and operated with a high degree of inspection readiness. CSV Lead for the implementation and migration of Legacy Baxalta's JD Edwards platforms into Shire’s SAP environment for Europe, Canada and the US.o Implemented six on-time, compliant deployments in eight months, including two sets of parallel releases.o These implementations enabled Shire to exit Baxter TSAs (Technical Service Agreements) thus preventing substantial financial penalties.o Created Audit packages for Shire personnel to identify and locate validation documentation during European and FDA inspections. This proactive approach allowed immediate presentation of documentation to inspectors preventing inspection observations.Supervised and approved vendor validation deliverables for the REMS program for Natpara and Gattex. o Addressed all FDA concerns allowing full deployment of these products for patient use.Participated in the development of Shire’s first Data Migration SOP, leveraging prior migrations and the ETL (Extract, Transform, Load) process.o The new SOP became the standard process for which all migrations and system integrations.CSV Lead for the LMS upgrade and new business process integration. Collaborated with the vendor, Saba, to confirm the use of a new private Cloud environment met Shire’s validation and data integrity standards.o This implementation allowed users to be on a single LMS platform for the first time, which allowed for streamlining of training and reporting information to regulatory inspectors.

Exton, Pa, Us

Senior Computer System Validation Consultant for R&D IT at Shire Pharmaceuticals Validation Lead for multiple technical and functional system upgrades to Shire’s Regulatory Submission system. • Each upgrade allowed Shire to submit Drug Applications to the FDA and European Agencies with the latest software and supported hardware resulting in fewer rejections from each agency.• Developed Shire’s first IT System Integration process by collaborating with the Technical Architect and Integration Director. Created new procedures (SOPs, Work Instructions, and Templates) and implemented the new processes. This newly documented and structured process enabled the R&D IT team to integrate all newly acquired companies in a consistent and compliant manner. • Received the 2012 MVP Award for demonstrating Jacquette values of consulting, work ethic, flexibility and dedication.

New York, New York, Us

Managed validation deliverables and timelines as well as technical application support for ISOtrain, the LMS implemented globally at Wyeth manufacturing sites.• Completed Consent Decree Inspection Readiness and Periodic Validation Reviews to ensure the application was operated and maintained in a compliant manner according to GxP guidelines. Identified and prevented 66% of the findings by completing the required activities prior to the final report submission.• Established the use of an electronic document management system for the ISOtrain team. Identified and created process improvements and best practices so that both hard copy and electronic documentation were easily accessible for FDA inspections.• Received the 2009 Learning is Essential Award from the business community for achieving the corporate goal of training business users in emerging markets.