John Ashby

About John Ashby

Global Service & Support Leader in the Biosciences & Medical Device industry. Established and led service teams in both the USA and EMEA (Europe, Middle East & Africa) and actively directed service teams on all 5 major continents. Established global service and support teams on complex new diagnostic instruments within regulated environments, whilst leading and managing new project launches and multiple service projects simultaneously. Responsible for the coaching, mentor-ship and career development of cross-functional team members. Represented my Division at numerous FDA audits and have a proven track record for timely project delivery, good project management, cost control and customer satisfaction.Key Skills:Team Development, Leadership and Management | Global Service and Support | Regulated Infrastructure Development | On-Market Support | Complaint Management | 510K Submission | R&D Integration | Business Process Implementation || Cross-Functional Collaboration and Stakeholder Management

Experience

1. Senior Manager of Technical Investigation

   FUJIFILM Biosciences

   Dec 2023 — Present · Irvine, CA, US

   Hired to establish a new team of Scientists, Engineers, and Compliance specialists, responsible for the full organizational technical support and complaint handling process. The role includes building out a new infrastructure to address customer inquiries, technical complaints, and product investigations, including full CAPA management for all business lines.

Education

• Leeds Beckett University

  BSC Honours, Biosciences & Health

  1996 — 2001

• Rotherham College of Arts and Technology (UK)

  Associate's degree, Business/Commerce, General

  1992 — 1994

• Leeds Beckett University

  Bachelor of Technology (BTech), Molecular Biology

  1994 — 1996

Skills

• Global Cross-Functional Team Leadership
• Polymerase Chain Reaction (Pcr)
• Micr
• Leadership
• R&D
• Hardware Diagnostics
• Medical Devices
• Capa
• Product Launch
• Biotechnology
• Research and Development (R&D)
• Team Building
• Management
• Troubleshooting
• Cross-Functional Team Leadership
• Project Management
• Field Service
• Pharmaceutical Industry
• Business Process Improvement
• Fda
• U.s. Food and Drug Administration (Fda)
• Quality System
• Molecular Biology
• Electronics
• Team Leadership
• Life Sciences
• Electronic Troubleshooting
• Biomedical Engineering
• Escalations Management
• Pcr
• Commercialization
• Customer Service
• Validation
• Mass Spectrometry
• Technical Documentation
• Product Development
• Lifesciences
• Field Support
• Microsoft Excel