Experience

BioIT Solutions

• United States
• Biotechnology Research
• 1 - 100 Employee

• Senior Consultant

  • May 2018 - Present

  BioIT Solutions is a leader in advanced computational, workflow and data management solutions for biotech research, drug development and diagnostics. We offer a range of services, from consulting in IT strategy, architecture and management to enterprise systems built on our 1Platform4 product suite. Our customers manage their important scientific data and intellectual property on a secure, responsive, and reliable internet platform that enhances productivity and adapts as their business grows in scale and complexity. Show less



Sucampo Pharmaceuticals, Inc.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Associate Director, IT Compliance

  • Mar 2017 - May 2018

  Executing processes and procedures to assure the compliance and quality of IT systems and solutions. Providing project and quality leadership for regulated and critical business systems to ensure compliance with all applicable regulatory and operational requirements. Acting as the liaison between IT and the applicable functional business departments to ensure understanding of operational compliance requirements and to establish how the IT projects meets those requirements. Ensuring compliance with internal procedures, maintaining records and providing quality and compliance oversight to IT delivery and change management processes across the company. Show less

• Senior Manager, Computer Validation & IT Compliance

  • May 2015 - Mar 2017

  Executing processes and procedures to assure the compliance and quality of IT systems and solutions. Providing project and quality leadership for regulated and critical business systems to ensure compliance with all applicable regulatory and operational requirements. Acting as the liaison between IT and the applicable functional business departments to ensure understanding of operational compliance requirements and to establish how the IT projects meets those requirements. Ensuring compliance with internal procedures, maintaining records and providing quality and compliance oversight to IT delivery and change management processes across the company. Show less



Independent

• Computer System Validation Consultant

  • Nov 2014 - May 2015



Avnet

• United States
• IT Services and IT Consulting
• 700 & Above Employee

• Senior Program Manager, Health and Life Sciences, Avnet Services

  • Aug 2013 - Nov 2014

  Project Manager of computerized system validation (CSV) projects and software implementations. Managed implementation teams and validation teams for Hewlett Packard Application Lifecycle Management (ALM) system for multiple pharmaceutical and biotech companies. • Led implementation and validation effort for ALM installation project for global Fortune 500 biotechnology company, including requirements gathering, customizations, qualification, training and deployment • Led installation, customization and migration effort for ALM upgrade for global Fortune 500 biotechnology company for >200GB implementation • Led customization, migration and validation effort for ALM upgrade for global medical device company that featured multiple (GXP and non-GXP) approval processes • Responsible for project budgets, schedules, resourcing and travel Show less



Genilogix

• United States
• IT Services and IT Consulting
• 1 - 100 Employee

• Computer System Validation Consultant

  • Apr 2013 - Aug 2013

  Project Manager of CSV projects and software implementations. As an independent consultant, managed Avnet employees on multiple projects. • Led a customization project for global pharmaceutical company that included custom report server development for automated, user configurable CSV documentation creation and interface and workflow customizations. • Managed in-house validation for eApprove tool • Performed GxP Training for Avnet employees on first week of job with one day lead time Project Manager of CSV projects and software implementations. As an independent consultant, managed Avnet employees on multiple projects. • Led a customization project for global pharmaceutical company that included custom report server development for automated, user configurable CSV documentation creation and interface and workflow customizations. • Managed in-house validation for eApprove tool • Performed GxP Training for Avnet employees on first week of job with one day lead time



Human Genome Sciences

• United States
• Biotechnology
• 400 - 500 Employee

• Senior Manager, Financial Systems

  • Mar 2012 - Mar 2013

  Program Manager of Ariba Procure-to-Pay system. Managed operations and support to end user community and Req to Pay personnel for the system and the associated processes. Managed multiple related projects pertaining to system operation and process efficiency.- Developed and operationalized day-to-day Procurement and Accounts Payable processes and procedures for issue resolution across all facets of Req to Pay, crossing technical and process areas- Gathered business requirements and implemented financial and administrative reports for multiple departments, including Finance and Accounting organizations- Managed issue resolution across all facets of Req to Pay, including technological, process and transaction issues- Developed company-wide training program spanning multiple creation tools and delivery methods- Coached, mentored and led Procurement and Accounts Payable personnel within a team environment Show less

• Senior Manager, Sourcing Solutions

  • Dec 2010 - Mar 2012

  Managed Procurement organization, instituting process and transactional standardization and establishing functional metrics, leading to improved throughput and a higher on-time payment percentage.- Managed the two-person Procurement team that served over 1000 HGS employees- Led business-focused requirements gathering and testing for Ariba Procure-to-Pay system implementation. As Program Manager, lead the administration, support and training effort for deployment covering over $200M spend annually Show less

• Manager, Sourcing Solutions

  • Oct 2007 - Dec 2010

  Delivered information technology solutions across Finance organization leveraging pre-existing and novel technologies to drive transactional efficiency and increase spend visibility.- Developed and deployed custom Spend Analysis database in Microsoft Access, increasing Strategic Sourcing's spend visibility to support their mission of obtaining the best products/services at the best value- Developed and deployed custom invoice approval tracking database in Microsoft Access, bringing Accounts Payable supplier payments from sub-60% to over 95% on-time- Developed and deployed company-wide P-Card Program covering over $2M spend annually Show less

• Computerized Systems Validation Manager

  • Apr 2003 - Oct 2007

  Developed and managed CSV program covering over 50 systems company-wide and led effort to standardize and streamline all CSV-related processes- Authored and implemented CSV policies and procedures across HGS resulting in world class GxP infrastructure. Influenced senior management and harmonized business practices across the organization resulting in efficient CSV processes.- Developed and championed processes to utilize web-based CSV management software (HP Quality Center and QuickTest Professional) to facilitate the automation of system qualification and regression testing- Directed activities for software engineers performing system development and validation- Prepared and presented overviews of CSV program to senior management and regulatory agencies as necessary Show less

• Senior Software Engineer

  • Jan 1998 - Apr 2003

  Managed the Process Control group. Led the group responsible for selection, design, documentation, installation, programming, commissioning, and validation of process control systems for HGS- Developed and executed the design, implementation, and validation of two plant-wide process control systems



TSI, Inc.

• Software Engineer

  • 1994 - Jan 1998

  - Provided a wide range of services on various contracts for a professional and technical services firm including project management, systems analysis, systems development, systems integration and Local Area Network support - Enhanced the efficiency of validated test article tracking and laboratory automation systems using innovative information systems techniques and methodologies, including programming in Clipper 5.2 and Access 1.0/2.0 - Designed and developed multi-user chemical inventory system with buffer recipe formulation. Performed measurement calculations based on changing base components. Co-developed multi-user chemical inventory system for hazardous material storage information Show less



Lockheed Martin

• United States
• Defense and Space Manufacturing
• 700 & Above Employee

• Software Engineer

  • 1991 - 1994



Tech Bookstore

• United States
• Accounting

• Floor Clerk

  • 1988 - 1988