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

* 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.

Listed skills include Pharmaceutical, Biotechnology, Medical Device, Gmp, and 44 others.

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  University Of Maryland College Park

  Analytical Chemistry