Working with pharmaceutical and medical device Fortune 500 companies on large-scale Document Management System upgrades and enterprise Quality Management System implementation projects.• Strategic Program/Project Management • Stakeholder Communications• Technology Implementation Expertise• Project Deliverable Creation• Content & Data Migration Planning

Manage the Global Quality and Compliance (GQC) Metrics & Reporting program by providing monthly and quarterly reporting on the state of the Quality Management System to executive and senior leadership teams, regional managers and other key stakeholders. Responsible for providing thought leadership in metrics development as well as managing the processes and procedures necessary to ensure proactive, consistent, complete and thorough oversight of the Quality Metrics & Reporting Program. Scope of reporting: management reviews, global quality scorecards and departmental reviews.

Senior analyst for the Global Field Surveillance (GFS) organization, providing direct technical support/data management and oversight of the post-market complaint reporting systems to ensure information retrieved is consistent, accurate and complete. Technical expert in GFS for data management, reports and queries.

*Responsible for operationalizing Fee For Service (FFS) incentive agreements for the major wholesalers including: electronic data (EDI) mapping, maintaining incentive accruals, determination of compliance and issuing payments.*Led the Distributor/Wholesaler Acquisition Pricing process, ensuring timely and accurate system maintenance and notification of pricing changes to trading partners and other stakeholders.*Provide customer eligibility and contract expiration information in response to trading partner inquires.

*Expertise in data extraction, manipulation and managing data files*Provide routine and as-requested data to multiple Corporate, Divisional and Plant functions*Analyze data output and identifies and communicates trends to management team *As a high-end user of Excel, experienced with using Vlookups, creating macros and using pivot tables to analyze data more effectively

*Led organization in applying for and achieving Level 2 Recognition by the Lincoln Foundation for Business Excellence (Illinois’ version of the Malcolm Baldrige National Quality Award)*Led cross-functional teams in assessing compliance to ISO 9000:2001 Quality System standard *Reported results of quality system audit analysis to management team members and worked with them to develop and execute corrective actions plans*Oversaw customer complaint process including managing database, guiding team members on developing timely and effective corrective and preventive actions, and reporting on performance to executive management*As an quality system auditor, interfaced with all areas of the organization including: Operations, Innovation, R&D, Finance, HR, IT as well as the Senior Management Team*Experience with mapping processes to improve efficiency and effectiveness

*Developed complaints management and non-conforming product data bases in Access, wrote queries, created management reports and charts to track performance*Developed and maintained complaint management process from receipt of complaint through ensuring effective corrective and preventive actions*Oversaw the non-conforming product process including managing data, training users, ensuring corrective and preventive action plans for highest failing parts *Led internal quality audit team to complete annual audits of the quality system and reported the results to management*Worked with management to improve reporting methodology to meet changing business needs *Extensive experience developing and managing Access databases, creating queries/reports and analyzing data