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Transforming Businesses with Strategic IT, GxP Compliance, and Proven Leadership

Driving digital transformation and operational excellence in highly regulated industries through strategic automation, seamless system integration, and innovative technological solutions

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About Guy

Driving Excellence in a Complex World

With over 20 years of seasoned leadership in IT, business strategy, and project management, I specialize in delivering innovative solutions and operational excellence for global organizations. My career is defined by successfully navigating complex, regulated environments—particularly in Life Sciences, Pharmaceuticals, and Manufacturing—to enhance compliance, streamline operations, and achieve significant cost efficiencies.

I bring a potent combination of strategic vision and hands-on execution, leveraging methodologies like Lean Manufacturing and Six Sigma. My expertise lies in spearheading digital transformation initiatives, deploying robust Enterprise Quality Management Systems (EQMS) like TrackWise and SAP LMS SuccessFactors, and ensuring unwavering adherence to standards such as 21 CFR Part 11 and GxP.

Credentials

  • Master of Business Administration (MBA), Technology Management & Information Systems – Tel Aviv University
  • BSc in Industrial & Management Engineering, Management Information Systems – Technion - Israel Institute of Technology
  • Languages: English (Full Professional), Hebrew (Native/Bilingual), Spanish (Limited Working)
Guy Chenya - IT & Quality Systems Leader

I excel at building strong relationships with top management and stakeholders, fostering self-directed, high-performing teams, and creating results-driven environments. My commitment to quality delivery and customer satisfaction is paramount, consistently leading to successful project outcomes and enhanced organizational capabilities.

Areas of Expertise

Strategic Project & Program Management

  • Leading complex, global IT and business application projects from inception to successful completion
  • Expertise in Agile and Waterfall methodologies, ensuring on-time, within-budget delivery
  • Proficient in risk management, stakeholder management, and cross-functional team leadership

Quality Management Systems Implementation

  • Global deployment and validation of EQMS platforms including TrackWise® and SAP LMS SuccessFactors
  • Ensuring strict adherence to 21 CFR Part 11, GxP, cGMP, and other regulatory standards
  • Harmonizing quality processes across multiple sites for global consistency and efficiency

Computer System Validation & Compliance

  • Managing Global Computer Validation Programs, defining and deploying GxP computer system standards
  • Expertise in validation protocols (IQ/OQ/PQ), data integrity, and audit readiness
  • Providing technical direction for complex CSV challenges

Digital Transformation & Excellence

  • Leading digital transformation initiatives to streamline operations and improve efficiency
  • Applying Lean Manufacturing and Six Sigma principles for process improvement and optimization
  • Developing and implementing centralized Master Data Management (MDM) systems

Business Analysis & Process Reengineering

  • Analyzing complex business needs, gathering requirements, and designing optimized workflows
  • Developing standardized processes and best practices for system implementation
  • Creating comprehensive documentation and process maps for quality initiatives

Training & Workshop Leadership

  • Designing and delivering effective training programs for administrators and end-users
  • Facilitating Kaizen events and workshops to drive process improvements
  • Developing change management strategies for new system implementations

Proven Results

Tangible Impact for Organizations

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Global SAP LMS deployment - Ensuring 21 CFR Part 11/GxP compliance across multiple Teva Pharmaceuticals sites
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Reduction in system downtime at Teva Pharmaceuticals by improving cross-functional efficiency in validation strategies
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Successful global deployments of TrackWise, harmonizing key quality processes across global manufacturing sites
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Reduction in support requests at Ness Technologies through effective user adoption strategies
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Reduction in implementation time for TrackWise rollouts through standardized processes at Sparta Systems
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Improvement in production efficiency as a Lean Project Manager at Mul-T-Lock Technologies

Contact

Ready to Transform Your Operations and Ensure Compliance?

Let's discuss how my expertise can drive your organization's success.

guy.chenya@gmail.com
LinkedIn
Available for Global Opportunities
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