Experience

Otsuka America, Inc.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Executive Director

  • Oct 2020 - Present

• Sr. Director, Facilities and Process Excellence

  • Jan 2019 - Oct 2020

  Responsible for using Six Sigma/Lean methodologies to implement continuous Improvement across key Otsuka processes. In addition, responsible for the optimal use of our Facilities to drive employee productivity and drive Customer Experience.



Otsuka Pharmaceutical Companies (U.S.)

• Pharmaceutical Manufacturing
• 700 & Above Employee

• Sr, Director, Business Services

  • May 2012 - Dec 2018

  This customer centric organization delivered excellent Customer Experience in the following areas: IT Infrastructure, Facilities Operations, Information Resource Center, Crisis Management, Business Continuity and IT Quality Management.Re-design of the IT Infrastructure Services Team: Implemented improvements in the following areas: Information Security, Cloud Migration, Improved Customer Facing Services, Infrastructure costs and improved customer delivery of projects.Led the new design and construction for new Otsuka US Headquarters – Researched the most current open space design concepts with leaders at MIT, visited multiple facilities and then designed a collaborative, technology supported work environment. Led the overall design with architects and oversaw the construction of the new $25 million facility. Developed a comprehensive change management program as people moved from a traditional office environment to a more open/collaborative environment. Excellent results recognized by the CEO from Japan.Implementation of Service Now – Implemented Incident Management and Change Management processes resulting in full visibility of all IT issues. Led the development of a customer self-service portal for the Facilities/Office Operations functions. Net result was a 50% decrease in cycle time resolution, resource optimization and improved customer satisfaction.Creation of a Business Services Delivery Desk (aka Apple “Genius” Bar concept) – This walk-up model addressed all Business Services requests in a more timely manner. The net cost savings result was $250,000 annually with improved customer satisfaction.Quality/Compliance Program expansion – Implemented a broader Quality program in addition to the existing Testing & Validation functions. This included conducting audits of new system vendors and developing a Quality risk assessment program. Created a Quality Management System for 2 new state of the art Digital Health products. Show less

• Senior Director, Information Technology

  • Feb 2009 - May 2012

  Hired to “run IT like a business” with strong delivery results, improved financials and strong customer satisfaction. Served as chief adviser to the Sr. VP of IT by facilitating leadership meetings, managing the IT budget and serving as key liaison to Japan leaders.Vendor Management Office (VMO) – Created VMO identifying core vs. non-core functions, developed Managed Service Provider (MSP) strategy for outsourcing and created operational SLA’s. Strong business outcomes resulted in the creation of a Strategic Sourcing Office @ Otsuka.Portfolio Management Office (PMO) – Developed a complete PMO program with SOP’s, project metrics and increased project capabilities. Result was a culture of high performing projects along with the highest number of IT projects completed @ Otsuka (over 75 per year).Testing & Validation – Implemented a global Managed Service Provider (MSP) to support new system development, system enhancements and infrastructure testing. Implemented automated tools to reduce paper records and increase global efficiency. Net result was over 75 projects being completed on an annual basis with an excellent compliance audit record. Multiple FDA and external audits resulted in no major observations. Show less



Johnson & Johnson Health Care Systems

• United States
• Hospitals and Health Care
• 300 - 400 Employee

• Director, Computer System Validation & Customer Experience

  • Jan 2007 - Nov 2009

  Oversee all aspects of the emerging Computer System Validation and Customer Experience functions. Manage an external consultant team of 8 members tasked with validating the Medical Device & Diagnostics (MD&D) division’s new $150M SAP order-to-cash program in order to improve service quality, efficiency and customer experiences. Function as Quality & Compliance Leader of the Program Management Office charged with ensuring adherence to project plans, validation documents, processes and FDA regulations. Conduct internal assessments; develop standard operating procedures and training programs; and, improve change control processes to align operations with the Management Action Plan. Liaise with customers at benchmarking and best practice seminars to identify and translate their needs and requirements into strategic action plans. Deliver performance updates to executive management teams, communicating key issues and improvement initiatives. Reporting to company President. Show less

• Director Quality & Compliance

  • Jan 2005 - Dec 2006

  Managed key business functions impacting Supply Chain operations, including process development, quality management, Sarbanes-Oxley compliance as well as safety and environmental programs. Coordinated all quality and compliance projects for the new Memphis Logistics Center. Implemented quality systems best practices to ensure organizational adherence to FDA Quality System Regulations.



Ethicon - Johnson & Johnson

• IT Services and IT Consulting
• 100 - 200 Employee

• Plant QA Manager

  • Jan 1999 - Oct 2001

  Directed all aspects of quality assurance and compliance functions at Ethicon’s Somerville Headquarters, including Quality Assurance Labs, Sterilization and Finished Goods Testing divisions. Challenged by senior management teams to improve under-performing quality results. Served as the Quality Representative of the Supplier Quality Management Group; tasked with supporting certification activities and corrective / preventative actions. Supervised 10 direct reports and a staff of 40 members. Directed all aspects of quality assurance and compliance functions at Ethicon’s Somerville Headquarters, including Quality Assurance Labs, Sterilization and Finished Goods Testing divisions. Challenged by senior management teams to improve under-performing quality results. Served as the Quality Representative of the Supplier Quality Management Group; tasked with supporting certification activities and corrective / preventative actions. Supervised 10 direct reports and a staff of 40 members.