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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.
EDUCATION
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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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