SUMMARY

Over 15 years of experience in diverse functional areas including Project Manage

ment, Product Management, Customer Support & Training, Product Development & Mar
keting. Directed the project management functions for BREG's New Product Develop
ment team in Vista, California; Watson Pharmaceuticals' Method Revalidation team
in Corona, California and IBM's Tivoli Event Services Manager (TESM) software d
evelopment team in RTP, North Carolina.
* Certified Project Manager (PMP)
* Resource Planning
* Marketing Research & Analysis
* House of Quality / Voice of Customer
* Developing SOP & Validation Plans
* Design Control & Phase Reviews
* FDA/Quality System Regulations (21 CFR 820)
* Negotiating & Consulting Skills

PROFESSIONAL EXPERIENCE
BREG, Vista, California 2007 - 2010
MEDICAL DEVICE MANUFACTURER OF ORTHOPEDIC PRODUCTS
PROJECT MANAGER, NEW PRODUCT DEVELOPMENT
Directed and influenced functional authority for planning, organizational contro
l, integration, and completion of product development projects. Responsible for
all goals and objectives of project, including completion within prescribed tim
e frame and funding parameters.
Established and implemented appropriate strategies, deliveries and comprehensive
cross-functional project plans for new products, including task analysis, work
breakdown structures, timelines, cost projections, resource requirements and ris
k/contingency plans.
* Introduced to BREG and implemented PMI's project management methodology to dra
stically improve on time product launches and best in class project management p
rocesses.
* Led the team in completion of House of Quality & Voice of the Customer to ensu
re that all the customer needs were met to increase the success of all product l
aunches.
* Led the New Products Development projects working with a wide variety of funct
ional areas such as sales, engineering, marketing, manufacturing and operations
to ensure on-time completion of projects.
* Conducted Lessons Learned and Post Market Surveillance at the completion of ea
ch project to review "What went well?" and "What can be improved?" going forward
on future projects.
* Developed and implemented methods and procedures for managing the status of pr
oject milestones, including preparation and delivery of progress reports to info
rm executive management of current project status.
* Managed conflicts of project personnel to provide counsel and resolve challeng
es.
* Ensured all regulatory requirements are met on all projects.
* Provided performance feedback for each participant on the project to appropria
te organizational manager.

Watson Pharmaceuticals, Corona, California 2004 - 2007

GENERIC DRUG MANUFACTURER
PROJECT MANAGER, LABORATORY OPERATIONS
Managed a $7 million project, consisting of 30 analysts, 2 Watson sites, and 6
Contract Laboratories to revalidate test methods for Watson's Laboratory Operati
ons. This 3 year project with high visibility to C-Level and V-Level executives
and strict FDA commitments & timelines involved a gap analysis and evaluation of
over 230 test methods for Active Pharmaceutical Ingredients (API) and Finished
Goods.
* Led cross-functional teams and developed detailed project plans for laboratory
operations to meet FDA/regulatory deadlines.
* Saved Watson over $500,000 by negotiating with contract laboratories and devel
oping a fixed price model for Method Validation and Method Development.
* Communicated critical project metrics, such as on time project completion perc
entages, statistical analysis of project duration, with Watson Director, Vice Pr
esident and CEO.
* Communicated issues and delays to upper management in a timely manner and reco
mmended solutions to minimize risk and project delays.
* Developed a document repository to facilitate ease of sharing various template
s, protocols and final reports with internal and external sources.
* Managed and motivated cross-functional team members, including Laboratory Tech
nical Services (LTS), Quality Assurance, Data Review, Documentation & Training,
Change Control and Regulatory Affairs to achieve project objectives.
* Developed process improvements and project tracking tools to better notify man
agement of milestone achievements and issues for resolution.
* Managed the selection and approval of contract laboratories and assured adhere
nce to Watson SOPs.
* Worked with Watson's legal department to complete all the required Confidentia
lity Agreements, Quality Agreements and reviewed site audits conducted by Watson
's Compliance group.

ISD Technology Group, Cary, North Carolina 2001 - 2004

MANUFACTURER OF BARCODE/LABELING SOFTWARE
REGIONAL PROJECT MANAGER
Provided project management to Fortune 500 companies in the Life Sciences indus
try by recommending & implementing a Zero Defect R3 solution for Product Identif
ication, Tracking & Tracing, Vendor & Customer Compliance.
* Developed all aspects of corporate projects including project plan, budget & r
equired resources.
* Ensured compliance to latest FDA regulations (CFR Part 11) and developed Stand
ard Operating Procedures (SOP) and Validation Plans for clients in the Life Scie
nce industry based on Current Good Manufacturing Practices (cGMP).
* Implemented PMI's project management methodology to improve and speed up produ
ct development, minimize risk and assure buy-in from the entire development team
.

IBM Corporation, Raleigh, North Carolina 1998 - 2001

SOFTWARE DEVELOPMENT TEAM
PROJECT MANAGER, TIVOLI EVENT SERVICES 1999 - 2001
Responsible for defining and maintaining a project plan document for every new
project outlining software development efforts, test parameters, manufacturing p
lans, product management as well as documentation and training efforts. Prepared
and presented weekly project status to development managers. Directed 6 interna
l development teams and established policies, guidelines and priorities.
* Developed and maintained detailed project plans and ensured that all milestone
s were met.
* Led cross-functional teams in new product development efforts.
* Ensured adherence to Tivoli's 7-Step Common Development Process.
* Managed defect tracking system administration (CMVC) to support user access, e
nsured that developers use system for code check-in/check-out, defect reporting
and build processes.
* Improved productivity by using a Notes/Web accessible database with all projec
t-related documents, including Market Requirements Document, System Architecture
, Release Contents Specifications, Project Plans, Design Change Requests and Fut
ure Requirements.
RELEASE MANAGER, WORK FORCE MANAGEMENT SOLUTIONS (WFM) 1998 - 1999
Supported Project Manager in task and resource planning and project development
. Conducted major milestone reviews and followed up on any open action items on
a weekly basis.
* Installed and provided technical support to 20 internal users for IBM's defect
tracking software.
* Informed and distributed new versions of customized software to WFM clients up
on release.
* Assisted System Verification Team with testing of WFM's Trouble Ticket Dispatc
hing software.

EDUCATION
BACHELOR OF SCIENCE IN MANAGEMENT SCIENCE & MARKETING
Bridgewater State College, Bridgewater, Massachusetts
MASTER OF BUSINESS ADMINISTRATION (MBA) - 4.0 GPA
Fayetteville State University, Fayetteville, NC

CERTIFICATION
PROJECT MANAGEMENT PROFESSIONAL (PMP) CERTIFICATION
MASTER'S CERTIFICATE IN PROJECT MANAGEMENT / IBM
George Washington University School of Business, Washington, D.C.

SKILLS
* Windows * Lotus Notes * Microsoft Office * Microsoft Project * Barcoding Softw
are*