James Bailey
Director, Site Technology and Launch at Pfizer
- Role
- Director, Site Technology and Launch at 辉瑞
- Location
- Raleigh-Durham-Chapel Hill, NC, US
- LinkedIn followers
- 500 followers
About James Bailey
Innovative professional with proven ability to identify, analyze and solve problems while working in cross functional teams in a schedule driven environment. Individual with experience in project management as well as pharmaceutical/biopharmaceutical manufacturing and validation.Specialties: Software: MS Office MS Project, MathCAD, SolidWorks, Scientific Notebook, Visio, Primavera Project Planner, Canvas 7.0, Groupwise, IsoTrain, GxPharma, TrackWise, LIMS (Laboratory Information Management System), SAP-CAPA Test Equipment: Kaye Validator, Mesa Data TracersProtocols / Standards: cGMPs, Pre-Approval Inspections, Annual GMP Inspections
Experience
Director, Site Technology and Launch
Jul 2025 — Present · NC, US
Education
Stevens Institute of Technology
Bachelor of Engineering, Engineering Management
1999 — 2004
Skills
- Gmp
- V&V
- Computer System Validation
- Capa
- Lims
- Vaccines
- Gamp
- Sop
- Fda
- Technology Transfer
- Quality Assurance
- Trackwise
- Iso 13485
- Validation
- Root Cause Analysis
- 21 Cfr Part 11
- Cleaning Validation
- Biotechnology
- Change Control
- Aseptic Processing
- U.s. Food and Drug Administration (Fda)
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