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 MANUFACTURER OF BARCODE/LABELING SOFTWARE
2001 - 2004
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 SOFTWARE DEVELOPMENT TEAM PROJECT MANAGER,
1998 - 2001
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*