- Senior IT Systems Leader
- Excels at implementing and managing major complex global GxP/Non-GxP information solutions
- Dynamic, technically sophisticated leader with expertise in business solution implementation, project management, budget/resource planning, regulatory compliance, and cross-functional collaboration. Over 15 years of hands-on experience in various IT roles. Proven ability to drive SaaS and Hosted platform system projects from conception to completion. Excels in system validation knowledge such as IQ/OQ/PQ. Proficient in maintain strict compliance with rigorous quality standards, including GxP, GAMP 5, and FDA 21 CFR Part 11. Strong team leadership, personable and engaging with the communication skills needed to build consensus on critical initiatives.
- Subject Matter Expertise
- Systems Development Life Cycle
- Budget/Resource Planning
- Cross Functional Leadership
- Computer System Validation
- System Release Management
- Learning Management Systems
- Pharmacovigilance
- Quality Management Systems
- Portfolio Management
- System Integration Analysis
| - System Change Management
- Vendor Management
- Data Migration
- Agile Scrum Methodology
- Pharmacovigilance
- Data Quality/Integrity
- Application Support
- System Architectural Design
- Data Analysis and Management
- Disaster Recovery/Business Continuity
- 21 CFR Part 11, Delivery, Processes, System Integration
- Agile, Disaster Recovery, Project management, Technical analysis
- Architectural Design, ERP, Project plans, Upgrade
- Articulate, Senior management, Quality, Validation
- Agency, Functional, Quality Assurance, Vendor Management
- Benefits, GAMP 5, Quality Management
- Budget, Gateway, Reporting
- Business process, IQ, Requirement
- Change Management, ISO, Requirements gathering
- Communication skills, Team leadership, Safety
- Consultant, Leadership, SDLC
- Continuous improvement, Managing, Software development
- Council, Meetings, SQL Server
- CRM, OQ, Stories
- Data Analysis, Oracle, System design
- Data Migration, PQ, Systems Development
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