Thomas Fu, Ph. D., Mcse, Cqa, Cba

Thomas Fu, Ph. D., Mcse, Cqa, Cba Email and Phone Number

Senior Vice President Global Quality and EHS @ HUTCHMED
San Diego, CA, US
Thomas Fu, Ph. D., Mcse, Cqa, Cba's Location
San Diego, California, United States, United States
Thomas Fu, Ph. D., Mcse, Cqa, Cba's Contact Details

Thomas Fu, Ph. D., Mcse, Cqa, Cba personal email

n/a

Thomas Fu, Ph. D., Mcse, Cqa, Cba phone numbers

About Thomas Fu, Ph. D., Mcse, Cqa, Cba

* Accomplished biopharmaceutical (small-molecule, biologics, & combination product) Quality management professional from the world’s leading biopharmaceutical companies, such as AstraZeneca Pfizer, Amgen, MedImmune, and Valeant, as well as virtual biopharma companies.* With 20+ years’ experience in GxP (GCP, GDP, GLP, GMP, & GVP) quality management systems (QMS), Quality Assurance, Quality Control, quality operation, quality engineering, data integrity, stability, validation, computer system implementation, quality risk management, regulatory inspections, and submission management.* Proven track records of hosting and leading cross-functional teams for the readiness of successful global regulatory inspections, including BIMO/CHMP clinical/GCP inspections, GMP/Pre-Approval Inspections (PAI), non-clinical laboratory/GLP inspections, and safety/pharmacovigilance/GVP inspections. * Successfully implemented Quality Risk Management/FMEA program to timely resolve critical / complicated investigations to prevent field alert reports, recalls, or clinical holds.* Consistently applied industrial standard methodologies, such as Fishbone/Ishikawa analysis, FMEA, risk management, statistics, SPC, Six Sigma, Operational Excellent, Kaizen, Lean, TQM, for the system establishment, investigation/root cause analysis, continuous improvement, and decision making.* Extended knowledge of biopharmaceutical product development life cycle, clinical trial, clinical operation, supply chain, manufacturing, laboratory control, analytical method validation, process validation, and commercialization.* Exceptional cross-functional team leadership, coaching, collaboration, conflict / problem solving, project management, people management / development, communication skills, and agile mindset.

Thomas Fu, Ph. D., Mcse, Cqa, Cba's Current Company Details
HUTCHMED

Hutchmed

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Senior Vice President Global Quality and EHS
San Diego, CA, US
Website:
hutch-med.com
Employees:
668
Thomas Fu, Ph. D., Mcse, Cqa, Cba Work Experience Details
  • Hutchmed
    Senior Vice President Global Quality And Ehs
    Hutchmed
    San Diego, Ca, Us
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  • Hutchmed
    Senior Vice President Global Quality & Ehs
    Hutchmed Mar 2021 - Present
    Us, Eu, & China
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  • Icp Consulting Service
    Principal Consultant
    Icp Consulting Service Sep 2020 - Feb 2021
    California, Usa
  • Kura Oncology, Inc.
    Sr. Director, Gxp (Gcp, Gdp, Glp, Gmp, & Gvp) Quality
    Kura Oncology, Inc. 2017 - 2020
    Kura Oncology, San Diego, Ca, Usa
    View
  • Astrazeneca
    Director, Quality, Site Quality Head (3-Shift Commercial Operations)
    Astrazeneca 2014 - 2017
    Redwood City, Ca, Usa
    View
  • Astrazeneca
    Associate Director, Gxp (Gcp, Gdp, Glp, Gmp, & Gvp) Quality
    Astrazeneca 2008 - 2014
    San Diego, Ca, Usa
    View
  • Amgen
    Principal Engineer, Validation / Quality
    Amgen 2006 - 2008
    Thousand Oaks, Ca, Usa
    View
  • Valeant Pharmaceuticals Intl Inc
    Director, Global Gxp (Gcp, Gdp, Glp, Gmp, & Gvp) Quality
    Valeant Pharmaceuticals Intl Inc 2005 - 2006
    Costa Mesa, Ca, Usa
    View
  • Pfizer
    Sr. Manager, Quality
    Pfizer 2002 - 2005
    La Jolla, Ca, Usa
    View
  • Medimmune
    Sr. Manager, Global Validation
    Medimmune 2001 - 2002
    Frederick, Md, Usa
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  • Biomerieux
    Manager, Qc & Laboratory Applications
    Biomerieux 1998 - 2001
    Durham, Nc, Usa
    View

Thomas Fu, Ph. D., Mcse, Cqa, Cba Skills

Pharmaceutical Biotechnology Medical Device Gmp 21 Cfr Part 11 21 Cfr Part 820 21 Cfr Part 4 Quality System Quality Operation Quality Engineering Validation Computer System Automation Capa Risk Management Fda Supplier Management Vendor Management Design Control Combination Product Iso 13485 Dhf Gcp Glp Gxp Non Conformance Investigation Erp Sap Lims Edms Aers Sop Calibration Oos Documentation Management Sdlc Pai Project Management Trackwise Product Disposition Process Improvement Quality Control Fda 483 Compliance Audit Chinese Ivrs Edc

Thomas Fu, Ph. D., Mcse, Cqa, Cba Education Details

Frequently Asked Questions about Thomas Fu, Ph. D., Mcse, Cqa, Cba

What company does Thomas Fu, Ph. D., Mcse, Cqa, Cba work for?

Thomas Fu, Ph. D., Mcse, Cqa, Cba works for Hutchmed

What is Thomas Fu, Ph. D., Mcse, Cqa, Cba's role at the current company?

Thomas Fu, Ph. D., Mcse, Cqa, Cba's current role is Senior Vice President Global Quality and EHS.

What is Thomas Fu, Ph. D., Mcse, Cqa, Cba's email address?

Thomas Fu, Ph. D., Mcse, Cqa, Cba's email address is tf****@****gen.com

What is Thomas Fu, Ph. D., Mcse, Cqa, Cba's direct phone number?

Thomas Fu, Ph. D., Mcse, Cqa, Cba's direct phone number is (301)-398*****

What schools did Thomas Fu, Ph. D., Mcse, Cqa, Cba attend?

Thomas Fu, Ph. D., Mcse, Cqa, Cba attended University Of Maryland College Park.

What skills is Thomas Fu, Ph. D., Mcse, Cqa, Cba known for?

Thomas Fu, Ph. D., Mcse, Cqa, Cba has skills like Pharmaceutical, Biotechnology, Medical Device, Gmp, 21 Cfr Part 11, 21 Cfr Part 820, 21 Cfr Part 4, Quality System, Quality Operation, Quality Engineering, Validation, Computer System.

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