HEALTHCARE PROFESSIONAL with 20 years experience in pharmaceutical, medical device and clinical environments.  Demonstrated ability to lead supply chain, information systems, and compliance initiatives.  Innovatively revamps processes and organizational structures to meet changing market needs.  Balances current business position with future opportunities to apply best practices.  Excellent track record of effectively managing program portfolios, staffs of up to 25, and $7.5MM budget. * Strategy Creation & Execution* Prospective & Retrospective ROI Analysis* Process Maps, Gap Analyses, & Roadmaps* Change Management* Regulatory & Standardization Leadership* Risk Assessment & Remediation

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Work History

Work History
2009 - 2012

Director Healthcare

Business development driving supply chain standards adoption within the U.S. healthcare industry.  Guiding industry by translating regulations such as UDI, ePedigree and serialization into adoption strategies like GLN, GTIN and EPCIS.• Drafted comments in response to regulations such as FDA UDI proposed rule and Electronic Health Record (EHR) Meaningful Use, serving as both author and subject matter expert on regulations.• Developed business process impact map for product ID (GTIN) and data synch (GDSN) implementation.• Proposed and led annual software vendor readiness survey, added collaboration from two industry associations, resulting in clear understanding of software readiness while educating vendors to release new versions for GS1 standards. • Instituted SLAs, integrated project plans, knowledge base support practices, and dashboards in program management of commercial software, resulting in stable infrastructure and repeatable processes.
Jul 2004 - Mar 2008

Director, IS

Merck & Co.

Managed IS portfolio for and partnership with Global Clinical Supplies operation through alignment of business & IT strategies.Oversaw up to 25 internal and contracted staff with annual budget of $7.5MM.

  • Reduced projected annual spend by at least $10MM by leading delivery of supply chain management ERP system with analytical forecasting capability, operational automation, and master data inventory.Earned two Merck Awards by leading matrix team to develop, test, & implement releases for this multi-year project.
  • Led on-time completion of accelerated, full-spectrum IS integration for acquisition of Novacardia, including HR, telecomm, finance, research and all other systems and data.Completed gap analysis, risk assessment, and remediation to enable adherence to FDA submission deadlines and requirements.
  • Averted any compliance citations through timely direction of 21 CFR Part 11 remediation for all of Merck Research Labs, encompassing 250 different systems.Matrix-managed cross-functional project team of 12 direct reports with extended team of close to 50.
Aug 2003 - Jul 2004

Director Data Operations, QA & Regulatory Systems Manager

Fast Track Systems

Directed staff, processes, data quality, and P&L for IT operations, including data center and company-wide infrastructure.Provided IS support to Sales and Marketing. Established, executed, and monitored quality/regulatory strategies for this software manufacturer serving pharmaceutical industry.

  • Reduced operating budget 25% and decreased coding errors 15% through process mapping/optimization and staff reorganization in data operations.
  • Achieved first-to-market in industry for Protocol Design product by collaborating with cross-departmental team.Performed 21CFR11 gap analysis of product, led remediation analysis, and communicated associated new product requirements.
  • Established strategic goals and positioned company for 21CFR11 and ISO9001 compliance to ensure competitive advantage in marketing GCP applications to pharma/biotech industry.
Apr 2001 - Aug 2003

Vice President, Information Technology

Innovative Programming Associates

Led team of 10 in full SDLC development, technical support, operations, and QA. Collaborated to create corporate strategy, gap analysis, and resultant product roadmap. Provided on-site sales and installation support.Evaluated compliance with GLP and 21CFR11 guidelines; hosted multiple GLP auditors and communicated with FDA representatives as needed.

  • Presented to annual user group meetings with up to 150 global representatives for this pharmaceutical software manufacturer.Ensured clear definition of user needs and alignment of priorities based on level of demand.
  • Generated $400K in cost avoidance and saved two years in time-to-market by establishing and executing on strategy to interface with other products rather than redesign current product functionality.Cultivated vendor relationships and established two vendor synergies to maximize competitive positioning.
  • Identified and realized 30% in FTE annual savings and reduced time-to-market market from 30 months to 9 months by instituting innovative SDLC, standardizing architecture, introducing reusable components, and reorganizing department.
Apr 1996 - Apr 2001

Senior IT Engineer

Wyeth Research Labs

Designed and developed software solutions to meet Wyeth’s business requirements. Supported scientists and laboratory hardware and software systems associated with Discovery Research.

  • Managed multiple hardware and software solution projects in support of 250 scientists and 180 systems.Recognized with Service Award for responsiveness and innovation.
  • Reduced data entry time by 80% and cut data entry error by 99%, saving over $200K in budget annually. Automated acquisition and submission of chemical data by creating interfaces to coagulation and plate reader instrumentation.
  • Accomplished $100K reduction in annual budget and provided decision support to scientists by providing analysis and mining system for informatics (Pipeline Pilot) and assay management tool (ActivityBase).Championed pilot evaluation, purchase, integration, and training of vendor products.
May 1994 - Nov 1995

Senior Process Development Engineer

Created and implemented hardware/software solutions to automate bench chemistry and packaging for start-up medical device company that prevented rate-limiting assembly line processes.Provided IT desktop support and authored GMP SOPs.

  • Designed and programmed automated three-axis, multi-head UV gluing machine whereby glue was applied and cured in less than 2 seconds per device.
  • Enabled competitive advantage in accuracy by customizing and programming Zebra barcode printer to print read-out scales on plastics top covers to accuracy of +/- 1 mil.
Jul 1989 - Sep 1991

Electrical Engineer

Carried video switching products through design, manufacturing, QA, and FCC emission compliance.Designed circuit boards with CAD & programmed in Motorola assembly language.

  • Reduced part count 15% and design cycle time 20% by re-designing Burle's most sophisticated product line in video surveillance using firmware and circuit redesign.
  • Conducted FCC emissions testing on video switching products, changing circuit board design to meet federal regulations.
  • Engineered switching power supply for video switching module.Utilized electrical CAD for circuit design and AutoCAD to create circuit board layout.