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Tommy Lee

Associate Director at Regeneron
Intro Book
Seasoned professional with expertise in Knowledge Management, Document Management, and Business Analysis.
  • Claim this Profile
Location
Cambridge, England, United Kingdom, GB
Skills
  • Knowledge Management
  • Document Management
  • Information Management
  • Change Management
  • Documentum
  • Show all
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Bio

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Topline AI
Tommy Lee is a seasoned professional with expertise in Knowledge Management, Document Management, Information Management, Change Management, and Business Analysis. He has extensive experience in various industries, including pharmaceuticals, with a strong background in process improvement, quality management, and technology. Lee holds a Master's degree in Computation from The University of Manchester and a Bachelor's degree in Business Management from Newcastle University.

Credentials

  • New Manager Fundamentals
    LinkedIn
    Nov, 2016
    - Apr, 2026
  • Diploma in Business Analysis
    ISEB
  • Foundation in Service Management
    ITIL
  • Lean Sigma Greenbelt
    -

Experience

  • Regeneron
    • United States
    • Biotechnology
    • 700 & Above Employee
    • Associate Director
      • Jan 2024 - Present

      Global Development Quality, Technology and Compliance

    • Snr Manager, GCP Quality
      • May 2022 - Present

      Responsible for the ongoing delivery of a Veeva based Quality Management System in the GCP, GVP, GLP domain including quality event issue management and auditing.

    • Quality Improvement Manager
      • Jan 2021 - May 2022

  • Amgen
    • Cambridge, United Kingdom
    • Senior IS Analyst
      • Dec 2019 - Jan 2021
      • Cambridge, United Kingdom

  • Roche
    • Switzerland
    • Biotechnology Research
    • 700 & Above Employee
    • Head of Internal Operations PD Quality, Strategic Risk Management and Solutions
      • Dec 2016 - Aug 2019

      Led a global team of six – process leads and process specialists - with diverse responsibilities including project management, audit program management, reporting, resourcing and capability development.

    • Metrics, Reporting and Process Lead (contract), PD Quality Assurance
      • Dec 2013 - Dec 2016

      Developed Excel metrics for the Senior Leadership Team, and ad hoc reports for internal and external customers detailing audits, inspections, findings and CAPA.Documented and continuously improved various processes including PSMF production, Audit Certificate production and audit programme management.Project managed the migration of all PDQA document content (35,000+ records) to Sharepoint.Project managed the inaugural PDQA Annual Audit Compliance Report.

  • GlaxoSmithKline
    • Knowledge Management Consultant
      • Aug 2006 - Oct 2013

      A business role responsible for defining and delivering key projects to realise the Knowledge Management strategy for the Product Development business.

    • Clinical Trials Supply Chain Reporting Service Owner (secondment)
      • May 2012 - Apr 2013

      This secondment role was responsible for repackaging an existing, under-used reporting service to extract maximum value for the business and bring cultural change in making better data-based decisions.

  • GlaxoSmithKline
    • IT Project Manager/Business Analyst, GSK R&D
      • Sep 2002 - Aug 2006

      Responsible for both lean sigma process improvement projects and full Systems Development Life Cycle projects.

Education

  • 2001 - 2002
    The University of Manchester
    MSc, Computation
  • 1991 - 1994
    Newcastle University
    BA (Hons), Business Management

Suggested Services

This profile is unclaimed. These are suggested service rates with 0% commision upon successful connection

Industry Focus. “Biotechnology”

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