Skills

• Project Management
• Business Strategy
• Leadership
• FDA
• GMP
• Change Control
• Program Management
• Regulatory Affairs
• V&V
• Cross-functional Team Leadership
• 21 CFR Part 11
• R&D
• Validation
• Pharmaceutical Industry
• Strategy
• Medical Devices
• Six Sigma
• Leadership
• CAPA
• Process Engineering
• Supply Chain
• Biotechnology
• Quality System
• Computer System Validation
• Design Control
• Sop
• Technology Transfer
• ISO 13485
• Quality Assurance
• GxP
• SOP
• Corrective and Preventive Action (CAPA)
• Supply Chain Management
• U.S. Title 21 CFR Part 11 Regulation
• Verification and Validation (V&V)
• Standard Operating Procedure (SOP)
• U.S. Food and Drug Administration (FDA)