SUMMARY

• Agile/Waterfall methodologies and tools
• MS Project/ MS Project Web/Clarity/Primavera
• MS SharePoint 2007, 2010, 2012/ Visio
• Project/Process Management/Quality Assurance/ Regulatory Compliance
• Sales Force Automation, Oracle/PeopleSoft/Siebel CRM, SFA.com, Veeva
• Computer Systems Validation/ Retrospective Evaluation
• Enterprise Resource Planning/ Manufacturing Resource Planning II/MES
• Pre - Clinical and Clinical Expertise, Phase I-IVa
• LEAN Manufacturing and 5S
• Documentum, Remedy, PDM, JIRA, DOORS and TrackWise document repositories
• ICD-9 and ICD-10
• Automated (Rational Suite, Mercury Suite, Selenium) & Manual Testing Tools (Delta V, UCA, SCADA, CAD, PLC)
• LIMS, EMDS, CTM, CRM, EPIC and LMS implementations, migration and harmonizations

PROFESSIONAL EXPERIENCE

Confidential, Ft Knox, KY

Sr Program Director

Responsibilities:

• Planned, managed and lead multiple complex IT Infrastructure and/or Application Development projects of small to medium size and wide variety of complexity and length
• Provided in-person and remote medical software support to end-users, guiding them through the challenge of new system adoption
• Utilized gated Waterfall methodology
• Experience in developing and supporting on Microsoft Azure or other cloud based technologies
• Overseeing the fulllife-cycle development and implementation program for Legacy LMS, LIMS and EDMS systems and technical activities to ensure successful project execution and meeting of requirements
• Managed activities of subcontractors utilized to deliver the technical solution
• Created and communicated detailed requirements, solution proposals, business process designs (BPD) and business system designs (BSD) that meet the business needs
• Planned, lead, organized and controlled multiple project initiatives according to agreed upon scope, schedule and budget targets surrounding the new EMR Rollout
• Developed testing, reviewed and implementation plans with the CRM project manager, business groups, user groups and CRM VAR (implementation partner)
• Delivered end-user application for go-lives, new hires, and optimization
• Lead and direct the successful delivery of infrastructure design, systems integration, and product installation/customization services while ensuring that assigned projects adhere to the approved life

Confidential, Louisville, KY

Sr. Project Manager

Responsibilities:

• Directly responsible for managing the project budget working closely with the PMO and/ or project sponsor to manage and report on the project financials - including the estimates created during the funding process, the ongoing allocation of financial resources and the regular reporting of the state of the project financials.
• Lead a variety of projects including implementing new systems and services, application development, systems integration, operational efficiency improvements, process re-engineering, and infrastructure upgrades and deployments
• Utilized Azure and other PaaS technologies on a very large-scale environment
• Utilized Agile(for revenue generating projects) and Waterfall methodology
• Proactively manage changes in project scope, schedule and cost, identify risks, and establish contingency plans
• Drove agile development methodology including test driven development.
• Coordinated and conducted a review of the ICD-9-CM/PCS and ICD-10-CM/PCS coding chapters for potential coding and physician via a team approach.
• Establish metrics baselines and perform analyses to identify and eliminate systemic process issues

Confidential, CA

Sr. Project Manager

Responsibilities:

• Coached, mentored, motivated and supervised project team members and contractors, and influence them to take positive action and accountability for their assigned work
• Worked with Senior Management and other Quality staff to oversee the development and implementation of an FDA compliant Quality System for GCP/GAMP5/GLP activities, provided periodic updates to Senior Management regarding the Quality Systems, LIMS, and collaborated with Clinical Research / Clinical Operations personnel to ensure that clinical trials comply with SOPs, FDA regulations, ICH/GCP, 21CFR11, and international guidelines, as applicable
• Lead sales incentive plan design processes with input from leadership team. Designed commission plans based on business needs, market practices and competitive requirements
• I facilitated critical meetings for project kick-off, status reports, and steering committee meetings with senior leadership. I provided strategic and tactical leadership to successfully implement technology and service projects for the implementation of SFA project
• Conducted process improvement initiatives on Veeva
• Lead implementation of SharePoint 2007
• Identified and managed project dependencies and critical path

Confidential, Natick, MA

Sr. Project Validation Manager

Responsibilities:

• Employed project management best practices as governed by Program Management Office’s based project management framework including its process definition, templates and tools
• Maintained complicated schedules, develop project timelines, and manage people and materials to complete jobs on schedule and within budget guidelines
• Lead the migration of data to LIMS, CTMS
• Utilized Waterfall methodology and Agile
• Develop, deploy and test automation solutions in support of commercial biotechnology based Drug Product (DP) aseptic fill and finish operations
• Lead implementation of ERP/Workday
• Defined, lead and implemented quality and validation engineering in designing and development of products, during product transfer, and in steady state phases of manufacturing operations; ensured timely independent quality assessment of systems, reports, internal/external facilities and documents that meet the company standards for quality, content, and format
• Worked with the client to gather reporting requirements and design the reports in Crystal Reports and developed Crystal Reports for use in a large scale IT/PMO Modernization effort
• Applied analysis concepts, techniques, tools and standards to support assigned projects

Confidential, Billerica, MA

Sr. Systems Manager

Responsibilities:

• Authored Validation Master Plans, and lead the execution of concurrent projects at multiple sites.
• Maintained domain and technology expertise by keeping current with evolving testing methodologies and healthcare standards
• Lead review of performance against expectations, highlighting good results, and developing action plans to address concerns
• Utilized Waterfall and Agile methodology.
• Lead the GAMP validation compliance directive for Software Engineered Product Group, inclusive to their automated M-ERP II system, Sales Force Automation, Laboratory Equipment, Processes, Allen Bradley, Legacy Labware LIMS and Empower Systems
• Coordinated and aligned management of PLCs and SCADA systems at the plant sites in a consistent and repeatable process approved by Process Engineering group and the Research and Technology
• Verified maintenance of Epic applications and facilitates updates, new releases and system enhancements
• Provided DCS controls support to Capital projects(using DSS) for testing and startup assistance as well as assisting in daily troubleshooting, gathering data and analysis of available information
• Utilized serialization to detect longitudinal changes to data in adherence to 21CFRPart 11

Confidential, RTP, NC

Associate Director

Responsibilities:

• Collaborated with Clinical Research / Clinical Operations personnel to ensure that clinical trials comply with SOPs, FDA regulations, ICH/cGCP/GMP, and international guidelines, as applicable
• Maintained daily/weekly/monthly reports regarding projects, activities, and status of open requests and problems
• Functioned as the Quality Subject Matter Expert and leveraged that knowledge to steer non-conformances into compliance
• Utilized Waterfall and Agile methodologies
• Assisted the Principal Investigator in laboratory oversight of clinical and pre-clinical bioanalytical studies as an Associate Study Director/Associate Principal Investigator per GxP requirements on LIMS
• Created and maintained project plans to ensure timely completion of tasks, major project milestones, and resource allocation utilizing SDLC methodology.

Confidential, Winston-Salem, NC

Sr Manager

Responsibilities:

• Researched and advised senior management on latest software test trends as well as market needs
• Conceived, lead, planned, executed, and interpreted research in inhaled toxicology, physiology, and derma-toxicology studies.
• Provided harmonization of Labware LIMS and acted as the primary liaison between the laboratory and IT group for the development and implementation of new systems, and enhancement of existing systems
• Performed and evaluated costs analysis and vendor comparisons for projects to ensure cost-effective and efficient operations.
• Followed Waterfall methodology
• Measured feasibility of various approaches and make recommendation(s
• Tested and verified system and database models to ensure quality and integrity

Confidential, RTP, NC

Regulatory Manager/QA Manager

Responsibilities:

• Implemented software testing processes and best practices as well as implemented the test strategy (architecture, framework, tools, etc).
• Adhered to Waterfall methodology.
• Determined the scope of projects, the timeframe, and the resources required; developed and reviewed project and work plans
• Maintained daily/weekly/monthly reports regarding projects, activities, and status of open requests and problems and Updated Salesforce reports and dashboards when necessary and sales territory changes, tier changes, or changes in opportunity definitions may affect reporting results for the organization.
• Lead implementation of EpicCare Quality System and databases to ensure optimum performance
• Conducted internal audits laboratory audits and trained computer validation staff.

Confidential, Raleigh, NC

Regulatory Compliance Officer/ QA Analysis Manager

Responsibilities:

• Conducted SDLC life cycle coordinated projects.
• Managed 3 wave implementation of LMS.
• Identified opportunities for testing automation and facilitates creation of standardizedtest suites
• Served as business analyst for several pharmaceutical divisions.
• Adhered to established best practices for systems application development, deployment, monitoring, security, disaster recovery, and backups
• Worked with internal stakeholders to ensure that the Salesforce.com configuration supports business requirements. As required, managed Salesforce.com enhancement projects to support business needs