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LILLY  TEMPESTA

239-898-9876 Cell                                                                                           Lilly@aol.com         

 

SUMMARY

Extensive Program/Project and Portfolio Management experience in pharmaceutical and financial services (banking and insurance) focusing on information systems, roadmaps, process improvement, standardization and cost savings.

TALECRIS BIOTHERAPEUTICS - acquired by GRIFOLS (June 2011)

(April 2011 – Present) – Consultant, Impact Systems

·         Automated the Change Control Request (CCR) process.  The business units impacted included O­­perations, Raleigh Test Lab, R&D, Talecris Plasma Resources (collection centers across the US), and Canada.  CCR automation included (1) electronic creation, authoring, review, approvals, e-signature, 21 CFR Part 11 compliant version control (2) CCR Templates (3) CCR number assignment and tracking, queries and reporting utilizing Documentum (ECM) and CARA (Generis) software, utilizing an Agile approach.

COVANCE (June 2010 - to November 2010) - Program Manager, Independent Consultant

·         Established the IT Program Management Office as part of the acquisition of Sanofi-Aventis sites in Alnwick, UK and Porcheville, France

·         Led the IT planning effort to replace the networks, email, applications and laboratory systems.

·         Led the transfer of licenses, maintenance agreements and contracts with onshore and offshore vendors from Sanofi-Aventis to Covance.

STS CONSULTING (2007 - 2009) - Executive Director, Program Manager, Life Sciences Division

Cherokee Pharmaceuticals (Merck plant) - Riverside, PA (Client)

·         Managed the Program Management Office and oversaw the implementation of all of the applications and the infrastructure due to the divestiture of Merck’s Cherokee Danville plant to PRWT Services (since reacquired).  The plant is an Active Pharmaceutical Ingredient (API) manufacturing facility.  

·   30 major applications and databases were addressed, including manufacturing, quality, maintenance and engineering, environmental and safety, financial and human resources.

·   Merck’s network infrastructure was replaced, including establishing network operations centers at the plant and with SunGard, reconfiguration of the communications network, implementation of new network services, re-imaging all of the user workstations and re-addressing the IP.

·         Rolled out a new ERP system (Epicor Vantage) and other financial capabilities (Microsoft FRx and Real Asset Management, Inc.’s Series4000) in a very tight timeframe. 

·         Implemented Sparta Systems’ TrackWise Corrective Action Preventive Action application for manufacturing atypicals, safety, environmental and quality records; migrated open records and archived closed records from the Merck application.

·         Created new processes, the documentation to support them and post-implementation support throughout the business.

·         Developed System Life Cycle and cGxP Documentation to qualify and validate the applications and infrastructure to meet all regulatory requirements.

BRISTOL-MYERS SQUIBB (2001 - 2007) - Program Director, Technical Operations Division,

Independent Consultant

·         Established the Program Management Office and managed 123 projects at 18 plant sites in 8 countries to meet the FDA’s requirements of 21 CFR Part 11 Electronic Records and Signatures.  Generally managed 30 - 35 projects at any given time.

·         Reduced the costs of the program from $140M to $75M by ranking the projects from most to least critical and through a variety of strategic and tactical cost cutting measures while still achieving the goals of the business.

·         Standardized processes, manufacturing equipment and laboratory instruments, upgraded or replaced hardware, moved from standalone to networked applications, and revalidated the applications.

·         Established and managed budgets, reviewed and approved project plans and schedules, tracked progress, resolved issues and reported status to Divisional and Corporate senior management and Steering Committees.

·         Raised the bar and taught project management skills to Technical Operations managers and mentored them throughout the project life cycle based on the PMI Book of Knowledge. The approach is utilized on all projects throughout the organization as part of the Project Management Framework.

·         Led numerous reviews to verify compliance, measure success, gather metrics and ensure resolution of any findings; trained others in the process.

·         Provided advice regarding which applications and resources to retain as part of the acquisition of DuPont Pharmaceuticals.  Analyzed sites, technology assets, and resource skill sets to determine the best fit similar to involvement in Glaxo’s merger with SmithKline Beecham when at RWD.

·         Interacted closely on a regular basis with the Information Management, Global Strategic Services (Service Level Agreements and Infrastructure), and Global Strategic Sourcing, Finance, Project Accounting, Quality Assurance and Compliance, Laboratory, Manufacturing, Engineering as well as the Pharmaceutical Research Institute (R&D Division), vendors and contractors onshore and offshore to ensure that the program’s objectives were achieved.

·         Used SAP’s FI, CO, HR, MM, and QM modules with less usage of the others. 

·         OptIMize – Analyzed existing applications worldwide, aligned applications to business processes (organizational blueprint) and determined which applications to retire based on business value versus cost. Increased standardization and achieved cost savings while increasing the knowledge base.  Intended to achieve and maintain a competitive cost base, focus resources on high-value work, and streamline processes.

·         GMP Work Plan - Analyzed the extent of GMP (Good Manufacturing Practices) compliance worldwide and recommended opportunities for improvement

·         Assisted in the global implementation of Sparta Systems’ TrackWise Corrective Action Preventive Action (CAPA) system to improve cGMP compliance, standardize and streamline processes among all sites, prioritize work based on rankings, and consolidate reports and metrics to measure effectiveness.

OTHER EMPLOYMENT

·         RWD Technologies (2000 - 2001) - Principal, Internet Technologies and Systems Integration

·         Bank of New York Mellon (1998 - 1999) - Assistant Treasurer, Project Manager

·         Coopers & Lybrand (now IBM Global Services) (1997 - 1998) - Project Manager

·         New York Life Insurance (1989 - 1997) - Senior Enterprise Architect (1993 - 1997)

·         American Management Systems (now CGI Group) (1983 - 1989) - Senior Business Analyst

·         JPMorgan Chase (1981 - 1983) - Operations Analyst, Internal Consulting Group

·         BearingPoint (1979 - 1981) - Analyst

·         Congressional Research Service (1979) - Research Analyst

EDUCATION

·         New York University, Leonard N. Stern School of Business, New York, NY Careers in Business Program, accelerated business program for social science Ph.D.s, August 1981

·         Princeton University, Princeton, NJ  Ph.D. January 1979, MA June 1975, Politics

·         University of Vermont, Burlington, VT  BA Political Science, May 1972 magna cum laude

OTHER

·         Fluent in Italian and working knowledge of French and Spanish. 

·         Numerous courses and seminars, including: Management and Compliance, Security, Electronic Records, Manufacturing Systems Architecture Standards, Managing Changes to Computer Systems and Computing Environments

·         Ph.D. Dissertation - Investigated industrial organizations, the impact of management and organization on business operations, and interaction between economic and governmental structures.

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