Deb Lewis

Project Manager Specialist

Quality Management & Compliance ● Process Design, Improvement & Alignment

Planning & Analysis ● Business Execution ● Technology Integration

Data Management ● Business Intelligence Development & Data Analysis ● Visualization

Continuous improvement leader designs efficient, effective, and scalable business, IT and quality management initiatives that promote performance excellence. Ability to manage strategic change, leverage stakeholder offerings, and create balanced solutions. Excels in synthesis of complex information and communication of innovative ideas. Visualizes results and transforms research and analysis into clear pictures.

Highlights

10+ years in health care and public health administration, life sciences, medical device manufacturing, and higher education specializing in improvements to business and quality processes and enterprise electronic systems

Currently leading delivery of a global biotech alignment initiative managing multiple work streams as the principal project manager Collaborating with interdisciplinary teams to effect multi-site improvements

report to global executive steering committees on project status, resource utilization, and significant accomplishments or issues

established governance, communication, and escalation system to manage project objectives and risk and allocate resources

developed tactical project delivery process enabling 14 global teams to evaluate differences between sites and resolve issues with significant potential to affect commercial production

created guidance to set clear objectives and well-defined deliverable requirements building effective balance between structure and standardization for consistent decision-making and flexibility to leverage team expertise

built SharePoint dashboard to communicate project status, facilitate project management & accumulate documentation and records supporting outcomes

created and effectively execute project plan to ensure work is in scope and with KPIs drives progress toward critical required deliverables

Expertise

Core Competencies

strategic planning

project &business case development

continuous improvement

change management

gap analysis

quantitative & qualitative research & analysis

business & system analysis

business & technical writing

root cause analysis CAPA

document control

Technology

Enterprise systems

Visio

SharePoint

learning Tableau

limited SPSS, SAS, VBA

Advanced SQL

Experience

Project Manager, Global Quality Strategic Projects Bayer (contract)

2016

Leading manufacturer of specialty therapeutics in hematology Responsible for facilitating and monitoring progress toward quality system alignment, identifying and assisting to resolve significant issues

Lead and collaborate with inter-disciplinary project leaders: improve, design, and build business processes to manage scope, schedule, and deliverables for alignment of 14 major aspects of global quality system at 4 international sites, s with significant expansion of GMP commercial production and related capital projects for 4 biotech / pharmaceutical facilities

Senior Consultant HighPoint Solutions, Inc. Worldwide specialized IT services in life sciences and health care

2015

Philadelphia

New York

Responsible for customer engagement: design and manage proposal/project, conduct quantitative and qualitative research, pinpoint key findings, and communicate recommendations

International AIDS Vaccine Initiative (IAVI) Innovative science & clinical development for laboratory breakthroughs & promising vaccine candidates. Collaborated with global stakeholders; evaluated requirements vs. system design in gap analysis; identified inefficiencies and vulnerabilities and reported in an actionable assessment and executive presentation

Charted course to streamline and achieve fully-integrated enterprise system, speed and enhance multi-continent collaboration, reduce compliance risk and simplify system administration by 50-75% while conserving resources of nearly 1.5 FTE nearly doubling ROI

Recommended new governance and process improvement strategy to solve unmet business requirements and improve technology-business integration

Data Quality Manager University of California, Berkeley University Relations

2014-2015

Berkeley

Oversaw customer-focused data management program for decentralized campus-wide $3 billion fundraising operations. Responsible for coordinating across multiple functions and departments to create and manage processes for data acquisition, processing and quality for accuracy, accessibility and suitability driven toward customer requirements

Accelerated ability for 36+ departments to use data consistently in online applications and IT systems revamped data management model aligning it with state-of-the-art technology (SOA, web-services) developers and business analysts build on

Standardized 60+ tasks into one process in less than 3 months by facilitating intensive business process improvement and re-engineering

Formalized business execution strategy and multiple project plans to position department to embody best practices and be the industry benchmark

Supervised and positioned technical service/data analyst team to:

Expand system functionality and increase data integrity

Fill gaps in delivering information targeted to specific customer need

Reduce cycle time for complicated requests while increasing handling predictability

Quality System Manager Food and Drug Administration (FDA) Office of Regulatory Affairs, San Francisco District

2010-2013

San Francisco District

Directed and collaborated to mature quality management system and harmonize operations nationally with 45+ offices; Managed quality processes & training. Led and participated in multi-disciplinary project teams:

Achieved ISO laboratory accreditation renewal within first year

Increased document accessibility and decreased critical loss by implementing 4000+ user electronic document management (EDM) system and deploying training

Overhauled internal business functions and quality processes resolved external audit findings, reduced unauthorized purchases and eliminated wasteful steps

Program Manager Denver Public Schools A diverse urban district of 73,000+ students, 150+ schools

2006-2010

Denver CO

Headed enrollment-forecasting program as of 2007 estimated state-sourced 50% of the $450M+ general fund Responsible for strategic program development, project planning, and execution. Evaluated constraints, conducted research, and quantitative and qualitative analysis working with diverse stakeholders. Directly impacted program, staff, facility sharing, and school closure decisions

Introduced behavior-based risk-sharing model to set district to be “industry” innovator

Partnered with IT to integrate processes Enabled multiple users to access data directly on-demand rather than by request in weeks

Hired as a data analyst to take over court-ordered 9-month reporting project. In 5 months, standardized and partially automated data model, analyzed data and completed project

Reduced time so that the project was doable in 6 to 8 weeks

Business Owner, Principal Artist Studio Bohēm’

2003-2007

Denver CO

Assistant Contract Manager Centers for Medicare & Medicaid Services (CMS)

1998-2002

Denver CO

Helped lay foundation of national Medicare integrity program in place today

Promoted in first 18 months to co-lead: design, implement, and manage operations of controversial first-of-kind federal contract ($8.5M) for risk-based data analysis and new use of operations research tools in payment integrity

Coordinated with peer experts to develop policy, define practices, identify and mitigate program risks, and redesign federal audits. Liaised with multiple national to local level agencies; researched laws regulation and policy. Conducted audits and reported findings in rarely met 30-day deadlines

Education

University of Montana Davidson Honors College Bachelors, Mathematics Applied Analysis & Operations Research; Bachelors, Art Ceramics & Painting; Presidential Scholar; Watkins Scholar Undergraduate Thesis Fellowship

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