SUMMARY OF QUALIFICATIONS

• Six plus (6+) years of management experience.
• Nine plus (9+) years of experience managing projects in a Pharmaceutical/ Biological/ Medical Device environment.
• Thorough understanding of 21 CFR Part 11 guidelines and GXP requirements.
• Excellent communications, organizational and troubleshooting/ problem-solving skills.
• Valuable interpersonal skills: quickly build and maintain good rapport with client/customer.
• Team player, self-motivator, ability to work with little or no supervision.
• Comfortable in a fast-paced, constantly changing environment.

EMPLOYMENT

Confidential (Consultant assigned to Ajinomoto AminoScience) 9/2010 – Present Sr. Validation Project Lead, SAP Project Implementation Team

Responsibilities:

• Project Liaison/ Lead between the Business (end-users), Quality, and the Technical teams to identify the user/ system requirements and manage the project timeline
• Develop all validation related documentation required to meet the project needs
• Work closely with the project team to determine the validation approach and provide guidance throughout the project
• Implement processes/methods to improve efficiency and promote consistent validation of systems
• Provide weekly project updates to Project Stakeholders / System Owners

Confidential 7/2007 – 1/2010 Sr. IT Manager, Data Management (1/2008 – 1/2010)

Responsibilities:

• Managed (full-time) staff of 5 in accordance with company policies and applicable regulations. Responsibilities include planning, assigning, and directing work; performance appraisals, addressing employee relations issues, and managing cost center budget
• Effectively communicated and interacted with all levels of associates and management within the organization; worked with external vendors on RFIs and RFPs for data cleansing and data governance efforts
• Developed, promoted and maintained the data governance structure per the business needs;
• Scheduled, organized and helped establish data governance council meetings
• Provided leadership and direction in site implementation projects, business process improvement and data standardization efforts, data quality and data integrity improvement initiatives, as well as system enhancements/ upgrade efforts
• Managed the creation of new and maintenance of existing SAP Master Data Standard Operating Procedures (SOPs), Forms, Training Material, and Data Standards used across all sites (Core SAP Objects: Material, Customer, Vendor and Quality)
• Developed and implemented the Data Auditing Program and the Data Change Management Process
• Coordinated and conducted new employee and refresher training for all Master Data Custodians and Stewards on the Data Entry and Data Maintenance Processes (8 active sites)
• Created and/ or reviewed and approved all data-related Change Controls and validation/ project documentation; managed all data-related CAPAs and deviations through to resolution
• Worked closely with the IT functional teams and business owners/ SMEs to identify issues and potential risks related to master data; proactively managed them to resolution and/or mitigation
• Provided bi-weekly metric reports to the business

IT Manager, SAP Project Implementation Team (7/2007 – 12/2007)

Responsibilities:

• Managed (contract and full-time) staff of 12 in accordance with company policies and applicable regulations. Responsibilities included day-to-day management of project staff, including work assignments, staff development, issue tracking and resolution, and monitoring work progress; managed the project budget
• Worked closely with all levels of associates and management within the organization to introduce and implement the new data governance/ data maintenance policies
• Created all project related documentation in accordance with the corporate ePMO standards
• Managed the development and implementation of global processes / procedures related to data management to ensure regulatory compliance and business requirements were met across all functional business units; 70+ SOPs, forms and Data Standards were created for this project
• Established a data governance structure, defined data ownership and stewardship, and developed, tested, and assigned the security Master Data Roles (currently 40+ security roles exist for Master Data Maintenance)
• Coordinated and conducted training for Master Data Custodians and Stewards on the new Master Data process
• Implemented and managed the Dual-Maintenance Program to ensure data residing in the new system was up-to-date until go-live
• Consolidated and cleansed master data from three (3) legacy ERP systems into SAP

Confidential 7/2006 – 7/2007 Sr. Project Manager, IT Quality

Responsibilities:

• Liaison between the Computer Validation Quality Assurance (CVQA), Information Technology (IT) and Quality Control (QC) groups; participated in internal audits as necessary
• Worked closely with the QC labs and IT project team to determine the validation approach and provide guidance throughout the project
• Created/ maintained QC and IT System Change Controls, Validation Plans/ Reports, Test Plans/ Reports, and System Release Notices.
• Reviewed and approved all Computer System Life Cycle Documentation: Business Requirements, System/ User Requirements, Design Specifications, Unit Specifications, Validation Protocols (IQ, OQ, and PQ), Configuration Management Plans, Support Plans, Data Migration Plans and User Documentation (SOPs, User Manuals, Training Material)
• Provided weekly project updates to Project Stakeholders / System Owners

Confidential 2/2006 – 7/2006 IT Business Systems Analyst/ Project Manager

Responsibilities:

• Liaison between the Users/ Business Owners and Technical Project Leads; analyzed the business process, gathered requirements, provided design solutions and process improvements
• Lead the Global Labeling Project; created all project related documentation in accordance with the corporate ePMO standards
• Coordinated all external vendor demos and was the main point of contact during the RFI and RFP process
• Effectively communicated project updates / status to Project Stakeholders / Sponsors
• Provided validation / compliance input/ guidance on multiply internal projects

ConfidentialSanford, NC 7/2004 – 1/2006 LIMS Team Manager/ QC Systems Compliance Project Manager

Responsibilities / Teams: LIMS Support Team Manager

• Managed the LIMS System support team (8 full-time employees and 2 contractors) in accordance with company policies and applicable regulations. Responsibilities include planning, assigning, and directing work; performance appraisals and addressing employee relations issues
• Managed the implementation, validation, and cutover process during the Labware LIMS Enterprise System project.
• Coordinated system upgrades with the Corporate Support Team; trained new team members provided technical support as necessary
• Maintained the systems’ validated state - managed requests in respect to system enhancements and new master data requirements; worked with Site Subject Matter Experts and the support team to determine scope of work, defined project and validation tasks as necessary, developed overall project schedules with critical tasks and milestones, and assigned resources to ensure deadlines are met
• Reviewed and approved all Computer System Life Cycle Documentation and change controls pertaining to the system; participated in internal and external audits as necessary
• Created all system administration SOPs to ensure compliance but provide flexibility when making master data changes
• Interfaced daily with multiple business units (i.e. Quality Control, QA Release, Manufacturing, IS, Technical Services, HR, Change Control, Document Control, SAP Team as well as the Corporate Labware LIMS Team) to resolve issues, determine best practices/ business processes or define new requests
• Met weekly with the QA/QC Director and Lab Managers to discuss the progress/ status of system changes/ enhancements and/ or to discuss issues

QC Systems Compliance Project Manager

• Oversaw all Quality Control (QC) validation projects - responsible for providing validation guidance and ensuring compliance issues are addressed appropriately within the QC Department/ Labs
• Developed a COTS Validation Process SOP and a Lab Systems Maintenance and Administration SOP
• QC Lead for the 21 CFR Part 11 Assessments and Remediation Project
• Reviewed and approved all, including but not limited to: Validation Plans, Risk Assessment Reports, Regulatory and 21 CFR Part 11 Assessments, User and Functional Requirements, Design Specifications, IQ/OQ/PQ validation protocols, Validation Summary Reports, and Decommissioning Plans
• As part of the Site Validation/ Compliance Team, worked with multiple business units to ensure site validation processes/ procedures comply with corporate policies and as well as GMP and Part 11 regulations

Matrix Resources/ Consultant 6/2001 – 6/2004
Client - ConfidentialClayton, NC
IS and QC Validation Project Manager

Responsibilities:

• Managed multiple (custom-built systems and COTS) projects simultaneously, developed project plans, coordinated all resources and tasks to include:
• Documentation, Validation, QA and Change Control in order to implement compliant systems
• Motivated/ managed team members to ensure an on-time delivery
• Gathered customer / system requirements and effectively communicated them to the team
• Assisted with all project efforts as necessary
• Ran weekly team status meetings and reported status to upper management / project sponsor
• Resolved project issues / concerns, and acted as primary customer point-of-contact to ensure absolute satisfaction.
• Worked closely with the End-Users/ Customer to create, review, and approve (as necessary) all Computer System Life Cycle Documentation: Project Charters, Validation Plans, Requirements and Design Specifications, Validation Protocols (IQ, OQ, and PQ), Final Reports, SOPs, and training material; Successfully managed and implemented (8) IS and (10) QC systems without missing a deadline
• Managed / supervised contract Validation Specialists - mentored/ trained new Validation Specialist on Bayer processes and procedures
• Developed and implemented the use of a COTS Validation SOP for the Quality Control department
• Trained approximately 560 users site-wide before the implementation of a new, compliant maintenance management system

Confidential RTP, NC 10/2000 – 5/2001 Technical Writer for Mobile Wireless Group

Responsibilities:

• Worked closely with Engineers on documentation development to include: user requirements, specifications, project plans, and participate in all project meetings
• Develop technical documentation which included writing and editing of hardware and software installation and configuration guides for mobile wireless products or solutions

Confidential RTP, NC 10/1999 – 10/2000 Business Analyst / Project Lead (January to October)

Responsibilities as Project Lead / Customer Liaison:

• Initiated and implemented a Parallel Development Project involving Engineers and Writers for Nortel Networks Service Operations Technology (SOT) to work as a team to develop Customer Specific Network Installation Documentation. This documentation focused on the physical installation, and was created by using the Network Engineering Documentation, any existing product documentation, and the Final Product Staging labs.
• Defined procedural flow, created a storyboard / method, and worked closely with the engineer or field personnel to technically verify the documentation
• Initiated and implemented the Template Revision Project and liaison to outside training vendor to provide training on and implement the use of new documentation templates
• Created project plans, created and/ or reviewed all documents before release, and test/troubleshoot new document environment/ templates
• Trained new Engineers on the documentation process and system

Responsibilities as Business Analyst:

• Completed an Assessment and Definition project for Nortel Networks Service Operations Technology (SOT)
• Assessed SOT current information development and delivery processes for installation information and ways to improve it
• Worked closely with the Customer to determine current processes’ jam points and short falls by developing a clear understanding of SOT role within Nortel and evaluated documentation for usability and accuracy
• Researched multi-media methods for documentation deployment and recommended ways to lower costs and development time
• Delivered a final report stating the project findings and recommendations for improvement

Confidential Raleigh, NC 5/1998 – 9/1999 Project Liaison/ Technical Writer

Responsibilities:

• Acted as Project Liaison between the USPS analysts and the customer to implement enhancements, resolve program issues, and validate that the Y2K test environment functions the same as the production environment
• Assisted the Team Lead in resolving documentation issues, completing status reports, creating project plans to assure deadlines were met and customer deliveries were made; trained new team members as needed
• Assisted in the development of the Assessment documents; created/ updated mainframe and client server user and system documentation to reflect all Y2K or other changes implemented in the program. Worked closely with the programmer/analyst and USPS representative
• Developed, edited and executed Y2K test cases

Confidential (Tech. Resource Group) - Raleigh, NC 9/1997 – 5/1998 Technical Writer

Confidential Buffalo, NY 3/1996 – 9/1997 Technical Writer

Pro American Educational and Cultural Exchange - New Philadelphia, PA 12/1992 – 6/1994 Public Relations Coordinator

EDUCATION

Associate Degree in Communication/Advertising
Bachelor Degree in Communications/Journalism