Shekri El-Khatib

About Shekri El-Khatib

Highly accomplished and results-driven Sr. Manager of Global IT Compliance, with technical expertise in IT Consulting, Security and Compliance, SDLC, Risk Management and Mitigation, and Computer System Validation. ITIL Certified. Master Certificate in IT Project Management.Technical Expertise in IT Compliance, Risk Management/Mitigation, Cyber Security (ISO-27001), Software Development Life Cycle (SDLC) and Computer System Validation 21 ÇFR Part 11. Comprehensive background in IT testing, Strategic Planning, and Quality Assurance. Track record of IT excellence in multiple industries. Knowledgeable in identifying and applying IT compliance standards and regulations, including Sarbanes Oxley (SOX), cGxP, ISO, 21 CFR Part 11, FDA Guidance in addition to global Regulations such as General Data Protection Regulations (GDPR), Health Insurance Portability and Accountability Act (HIPAA) and other legal and regulatory requirements. Organized and analytical, with ability to evaluate and advice on current and proposed IT systems and initiatives in relation to compliance and IT governance, System Controls that meet SOC, coordinate all IT Auditing activities. Knowledgeable in strategic planning and performance analysis. Results-driven and self-motivated. ITIL Strategy, Operation and foundation Certified, and currently pursuing ITIL Expert certification. Direct involvement in multiple acquisitions/mergers.Global leadership experience includes team collaborations throughout the world, including the United States, Canada, Europe and Asia. Successful track record in a broad range of projects, scopes, and industries. Exceptional history of deploying strategic initiatives.Gifted communicator, with a stellar reputation for clarifying strategic vision regarding compliance with current proposed IT systems and initiatives. Knowledgeable in performance analysis, and budget forecasting and administration.Management experience directing and guiding teams and managing projects and processes. Recognized for excellence in communication, with ability to establish rapport and build collaboration with team members at all levels. Accurate and detail-oriented.Experience serving as a Success Catalyst. Enthusiastic change agent, with a unique ability to motivate and develop future leaders. Demonstrated problem-prevention and problem-solving skills. Solutions-oriented and proactive. Stellar work ethic, with unwavering commitment and motivation to exceed established goals.

Experience

1. Senior Manager of Global Information Technology Compliance

   Luminex

   Oct 2010 — Present

   Provide strategic leadership and direction to ensure infrastructure compliance for the organization, worldwide. Evaluate, recommend, implement, and manage tools related to IT compliance and IT security, as well as all related policies and procedures- Recognized for implementing cloud-based solutions based upon ITIL standards, involving the Service Desk System (to manage incident tickets for the organization worldwide) and the Change Management System (to standardize the process for submitting new changes to the enterprise systems globally)- Managed the implementation and global rollout of the Help Desk system- Served as member of Merger/Acquisition Team when Luminex acquired EraGen Biosciences- Recognized for performance excellence with internal promotion.Director – IT ComplianceAs head of Information Technology, IT Compliance, and Computer System Validation, oversaw strategic IT planning and compliance, and provided direction regarding IT Change Management, IT Internal Audit, IT Document Control, and Application Validation. Managed company ERP system, VOIP system, and all aspects of qualification related to the IT network. Identified and implemented IT compliance best practices. Managed and delivered program and project management and design, and managed detailed budget forecasting and administration- Effectively led multiple large-scale, multi-faceted projects, and delivered each on time and within budget- Managed the IT Network Qualification System for Genzyme/Bonecare Corporation, and again for EraGen Biosciences- Developed and rolled out the company Computer Network Back-up Policies and Procedures, Computer System Change Management Policies and Procedures, Anti-Virus Procedures, and the Computer System Master Validation Plan.

Education

• Winona State University

  Computer Science

  1987 — 1992

• The George Washington University

  Master Certificate in Information Technology Project Management, Project Managemet

  2006 — 2008

Skills

• Corrective and Preventive Action (Capa)
• 21 Cfr Part 11
• Budgets
• Integration
• Process Improvement
• Cross-Functional Team Leadership
• Gxp
• Budgeting
• IT Solutions
• Computer System Validation
• Troubleshooting
• Quality Assurance
• Project Management
• Security
• Gmp
• Change Control
• Sdlc
• Requirements Analysis
• Validation
• Testing
• Sop
• Fda
• Program Management
• Medical Devices
• Capa
• Compliance
• IT Management
• Strategic Planning
• Management
• Change Management
• Itil
• Biotechnology
• Healthcare Information Technology
• Risk Management