Pharmaceutical consulting in all areas of Manufacturing/Quality Operations and Information Technology system implementation. Recent engagements have included:  Conducted numerous Data Integrity audits of manual processes, procedures and computer systems Provided PMO support and guidance for a global effort to identify a strategy for Product Knowledge Management (tools, processes, governance, etc.) for a top five pharma company Provided PMO support for a multi-site compliance and remediation project for a Division of a top five pharma company Conducted a GxP CSV audit of multiple IT systems for a top five pharma company Provided PMO support for a multi-site project to build, test and implement a global LIMS system Work stream leadership role on a project to design an automated process for the compilation of Annual Product Reviews  Work stream leadership role on a project to design and implement a global regulatory product information system  Performed a Quality and Engineering risk assessment at 5 nutritional manufacturing plants and worked with global leadership team to develop mitigation strategies  Facilitated process with a global manufacturing leadership team to develop a vision and strategy…this included the development of a 3 year strategic plan and identification of strategic initiatives and tactical projects to move towards the vision Completed a GxP audit of the Software Development Life Cycle processes at a German ERP software provider wanting to enter the U.S. market  Provided PMO support for a team that developed a Governance model for Integration Middleware Technology and Processes  Worked with various clients to identify process and GxP improvement areas and to develop mitigation plans

At the time of the formation of sanofi-aventis in 2004, I was named Head of Competitive Intelligence & PAT (Process Analytical Technology) within the Industrial Technology group. Prior to merger, I had the opportunity to work in various roles:Led a global project to design, develop, test and implement a common Electronic Batch Record System (EBRS), Laboratory Information Management System (LIMS), Data Analysis Tool (DAT), Data Historian (DHS) and install them at 5 sitesDirected the overall synergy plan for 35 plants in the Americas Asia Pacific (AAP) area. Facilitated development of overall manufacturing vision and strategy for the AAP group and developed (and gained approval for) a global strategy for PAT

Head of the manufacturing unit producing 3 Global Strategic Products (180 associates…3 billion doses per year…launched 2 new products).Developed overall capital strategy for the PPU and managed projects that included: construction of a new manufacturing area utilizing “cellular manufacturing technology”…”lights out” table compression suite…renovation of existing granulation areaImplemented a new organizational concept of PPUs based on a “plant within a plant” model

Led a multifunctional project team to design, develop, test and implement an Enterprise Resource Planning System (SAP), EBRS, LIMS and Laboratory Acquisition System (LAS) for 3 sites.

Represented Industrial Operations on the Executive Committee for Marion Merrell Dow Canada. Participated in an analysis of the plant network for MMD Canada and eventually implemented a decision to close the Richmond Hill facility. During the 18 months leading to the plant closure the site maintained an excellent safety record, maintained production schedules, launched two new products, transferred production to other sites, maintained employee morale, sold and closed the facility.

Various Operations Management postions from Supervisor to Department Manager