University of South Florida

Mercer University

University of Tennessee

Devise and execute operational strategies, including budgeting and resource planning for supply chain, engineering, field/depot services, call center and quality system teams. Collaborate with executive and functional leaders to develop contractual agreements with key suppliers.  Devised and executed a scalable systems architecture and roadmap that supported the strategic priorities of the Technical Operations organization, which included Supply Chain Management (SCM), Quality Assurance, Engineering, Field/Depot Service and Call Center teams.  Collaborated with executive and functional leaders to develop contractual agreements with key suppliers.  Created an unmatched digital ecosystem by developing and integrating Field Service E-Training, SalesForce Field Service, SAP Supply Chain, and SAP PLM AIN. 
• Translated the business vision into strategic product roadmaps leveraging an agile approach while delivering multiple products partnering with both internal and external resources. 
• Spearheaded a team of 5 cross-functional directors to build the operations infrastructure to launch a new Kidney Care business focused on Home Hemo Dialysis. 
• Created and implemented the SCM strategy for the Home Hemo Dialysis business that was inclusive of forecasting, purchasing, warehousing, and distribution.
• Onboarded two third-party clinical service providers via an accelerated process to supplement the clinical study team in collaboration with the enterprise procurement, legal and trade teams.
• Created, owned and managed both CAPEX and OPEX budgets leveraging zero-based budgeting.

CVS Health

Head Of Technical Operations

Led prevention of revenue disruption for the three largest small molecule sterile mfg sites ($555M VOP) by establishing best practices and implementing cutting-edge quality control and defect prevention technologies.

• Consolidated 15 teams with over 100 cross-functional resources into one integrated team with four key work streams.
• Spearheaded the integration of new systems, processes, and workflows to improve the networks OEE by 20% while reducing nonconformance and increasing resiliency.
• Created executive dashboards that integrated data from 30 plus facilities into one clear visual output.
• Managed $125M capital program and secured OPEX savings of over $75M across the network. 
• Accomplished 45% reduction in complaint incidents per million (CIPM) and 96% reduction in internal defects per million (DPM) rates on a key franchise small molecule sterile product line.

Baxter International Inc.

Director Of Engineering

Guided implementation of business growth plans for three business units encompassing 62% ($6.1B) of Baxter’s 2016 revenue.  Interfaced with BU presidents to ensure alignment on product rationalization across portfolios (including small molecule and combination products) to enhance network capacity for high-margin products.  Formulated enterprise-wide strategies to minimize capital expenditures resulting in $125M CAPEX avoidance. 
• Achieved annual COGS savings of $2M and capital expenditure savings of $12M by implementing product modifications and portfolio rationalizations for the Nutrition business.
• Directed both the 5 year and the annual strategic capacity planning process for 28 mfg facilities supporting three business units across six continents.
• Guided development of a technique to streamline a chemical process, doubling the existing production capacity and resulting in significant cost savings of $22M in capital expenditures.
• Implemented product modifications and portfolio rationalizations that resulted in $2M in annual COGS savings and the avoidance of $12M in capital expenditures.
• Employed lean mfg principles to optimize processes resulting in an increase in network capacity, reduction in COGS for key products and an increase in overall margin.

Director, Manufacturing Strategy

Supported the co-location of the majority of project team to reduce communication, product change management and internal issues while improving team engagement.  Championed the resource planning process with all functional areas under operations spanning four countries.
• Led the integrated supply chain operations and technical service activity related to technology transfer and scale up of a new combination device. 
• Allocated and tracked capital expenditures in excess of $39M across five internal mfg sites and two external sites in support of a product launch initiative.
• Managed the mfg and delivery of the investigational supplies and field service support for the clinical trial.

Director of Concurrent Engineering

Within 20 months, identified Contract Manufacturing Organization (CMO), negotiated contracts, localized supply chain and partnered with CMO to open an ISO 13485 medical device facility from a Brownfield location, within a special economic zone to support new product launch.
·	Led hardware contract manufacturing supplier assessments with facility evaluations in the US, Singapore, Malaysia, Japan, India and China for the Renal Division
·	Proactively worked with BU counsel and procurement leads to ensure program scope, business vision and must haves, prior to supplier engagement
·	Successfully localized a medical device raw materials supply chain to meet the special economic zone requirements in India

Sr Engineering Manager

• Led the hardware contract manufacturing and supported the contract design supplier assessments in India for the Indigo program
• Responsible for all hardware manufacturing activities related to Renal top two projects
• Led both internal and external cross-functional facility teams in eight countries for Renal NPD programs
• Successfully oversaw the management of the build, validation and registration (ISO 13485) of a greenfield in India by a third party manufacturer
• Managed capital expenditures in excess of $30,000,000
• Worked with PSM and Legal to develop and approve contract for 3rd party manufacturer
• Helped to integrate the Design for Manufacture and Assembly methodology into the product development process
• Responsible for both hardware product transitions to the Largo facility and supporting global Renal hardware transfers
• Led DFMA training sessions and workshops for other Baxter divisions
• Successfully created and led a cross-functional team of 30 plus engineers to implement a master validation plan for the Largo manufacturing facility
• Managed a team of 20 internal and external engineers, CAD specialist and IT specialist to revamp over 8,000 documents and create an electronic system for viewing manufacturing instructions
• Led the successful global launch of the Arena Renal Hemodialysis unit
• Successfully led a cross-functional team of senior level employees in a 24/7 operation to release a major product line from Corporate Hold

Manufacturing Project Manager

• Created global cost models and country level benefit analysis templates for global service managers to use to support product and reliability enhancement recommendations
• Executed worldwide product upgrades and retrofits for the Amicus product line
• Traveled to over 17 countries as the global liaison for Research & Development and Global Marketing to help secure tenders for the Transfusion Therapies business
• Worked with the local Chinese team to create a regional service center for two product lines

Global Service Technical Product Manager

• One of four quality team members responsible for creating the product analysis laboratory at the Largo facility
• Responsible for the identification, installation and management of the Acoustical Testing Lab
• Managed the product analysis of returned product for Transfusion Therapies and Renal divisions
• Using DMAIC principles, reduced the manufacturing facility inventory of returned products by 70% or
$1,000,000
• Using DMAIC principles, developed and implemented a tool that provided the North American Service Region with $250,000 in cost savings annually

Senior Quality Engineer

• Responsible for the daily engineering activities for the HomeChoice hardware product line
• Responsible for overseeing all the process improvements for the HomeChoice hardware
• Led the internal process for all supplier notifications of change for the HomeChoice line
• Specified, procured, installed and qualified equipment used in the HomeChoice manufacturing line

Walter Roach