James Brafford Email & Phone Number
Senior Vice President, Quality @ gel-e
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James Brafford Location
- Frederick, MD, US
James Brafford Work
- 2025 -now Senior Vice President, Quality @ Medcura, Inc.
- 2024 -now Chief Executive Officer @
- 2023 -2024 Senior Vice President, Head of Global Quality @
- 2018 -2022 Vice President, Head of Device Quality @
- 2018 -2018 Executive Director, Global Quality Management Systems @
- 2017 -2018 Executive Director, Global Quality Operations @
- 2014 -2017 Executive Director, Global Strategic Quality @
- 2012 -2014 Director, Global QRA Operations—Vital Signs Devices Division @
- 2008 -2012 Director, Global QA Distribution—Medical Diagnostics Division @
- 2005 -2007 Manager, Americas QA—Medical Diagnostics Division @
- 2003 -2005 Quality Assurance and Regulatory Compliance Manager @
- 2002 -2003 Quality Engineering Manager @
- 2001 -2002 Senior Quality Engineer @
- 2000 -2001 Senior Auditor—Corporate QA @
- 1999 -2000 Supervisor, Quality Assurance @
- 1996 -1998 Quality Control and Regulatory Compliance Manager @
- 1994 -1995 Analytical Lab Manager @
- 1993 -1994 Production Supervisor @
James Brafford Education
- Drexel University
MBA (Management of Production and Operating Systems)
1996-2000 - Bridgewater College
BS (Biology major/Chemistry minor)
1989-1993
James Brafford Skills
- Clinical Operations
- CMO management
- Product Complaints
- Terminal Sterilization
- Distribution Management
- Warehouse Operations
- Due Diligence
- Integration
- Strategic Planning
- Organizational Design
- Risk Management
- Regulatory Intelligence
- Quality Management System
- Mergers & Acquisitions (M&A)
- Organizational Development
- Team Building
- Product Acquisitions
- Good Clinical Practice (GCP)
- Product Development
- Combination Products
- Biopharmaceuticals
- Product Quality
- Manufacturing Operations
- Quality Systems
- CAPA
- Medical Devices
- Quality Assurance
- Auditing
- Compliance
- Manufacturing
- Clinical
- Complaint Handling
- FDA
- GMP
- Quality Management
- Pharmaceuticals
- GLP
- Continuous Improvement
- ISO
- Healthcare
- Supplier Quality
- Six Sigma
- QSR
- Root Cause Analysis
- Operations Management
- Quality Engineering
- 21 CFR Part 11
- GxP
- cGMP
- Pharmaceutical Industry
- Quality System
- V&V
- Clinical Research
- Sop
- Quality Control
- Clinical Trials
- Validation
- Complaint Management
- Biotechnology
- Regulatory Affairs
- ISO 13485
- Quality Auditing
- ISO 14971
- Design Control
- Computer System Validation
- Corrective and Preventive Action (CAPA)
- U.S. Food and Drug Administration (FDA)
- Standard Operating Procedure (SOP)
- Microsoft Word
- Communication
- Corrective and Preventive Action Capa
- Brachytherapy
- Training
- Multiple Sites
- Distributors
- Liaison
- u.s. Food and Drug Administration Fda
- Exceptions
- Strategy
- Situational Leadership
- Process Improvement
- Juice
- Problem Solving
- QC
- Project Management
- Data Validation
- Inventory Management
- Packaging
- Task Force
- Inspection
- Toastmasters
- Molecular Imaging
- IR
- Process Validation
- IV
- Accountability
- Agents
- Data Integrity
- Warehousing
- Contract Manufacturing
- Standard Operating Procedure Sop
- Nuclear
- Ethics
- Team Development
- Commitments
- Operations
- APIs
- Film
- Prediction
- Blood
- Management Review
- GCP
- Internal Audit
- Leadership
- Regulatory Compliance
- HACCP
- Financial Analysis
- Policy
- Customer Service
- DEA
- Printers
- Forms
- Reviews
- USP
- Engineers
- Cost Reduction
- Distribution
- Components
- FMEA
- Coaching
- Biologics
- R&d
- Statistics
- Profiling Tools
- Cfr
- Consumer Goods
- Windows Registry
- Laboratory
- Microsoft Excel
- Management
- Parenteral
- Human Error
- External Manufacturing
- Repository
- Supply Chain
- Circuits
- OOS
- Quality Improvement
- Investigation
- Sterility Assurance
- Parts
- Rubber
- Capas
- Batch Release
- Metrics
- Product Lines
- Officers
- GDP
- Suppliers
- Oversight
- Vital Signs
- Prescription
- Cosmetics
- DBMS
- Engineering
- Quality Operations
- Testing
- Equipment Qualification
- Decision Making
- Acquisitions
- SME
- Resources
- CMOS
- Standard Operating Procedure
- u.s. Food and Drug Administration
- Corrective and Preventive Action
James Brafford Summary
- James Brafford, based in Frederick, MD, US, is currently a Senior Vice President, Quality at Medcura, Inc.. James Brafford brings experience from previous roles at Providence Partners Consulting, LLC, DBV Technologies, Emergent BioSolutions and Allergan. James Brafford holds a 1996 - 2000 MBA in Management of Production and Operating Systems @ Drexel University. With a robust skill set that includes Clinical Operations, CMO management, Product Complaints, Terminal Sterilization, Distribution Management and more. James Brafford has 2 emails and 3 mobile phone numbers on RocketReach.
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