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Professional Services

⏤deliver business value

 

Project Management | Portfolio/Program PMO Value Optimization

Project Management professional leadership of diverse remote global cross-functional teams. Successfully implementing strategic improvements and solutions to complex problems—on time, on scope and within budget. Fostering a culture of learning, remote global collaboration and continuous improvement to simplify, automate and sustain process excellence—data-driven project excellence aligned with business strategy.

  • PMI-Certified Project Management Leadership

  • Project Expertise in FDA GxP, Medical Device, Pharmaceutical and Manufacturing

  • Enterprise Software Proficiency | eQMS, LIMS, ERP, Microsoft Power Platform

  • Fostering a collaborative environment where expertise is shared and team members are recognized and valued

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Global Quality eQMS | Implementation

OneTower eQMS implementation support delivers regulatory compliance and business value. Strategic implementation focuses on rapid deployment of best practices to automate key business processes, facilitate cross-functional collaboration, optimize end-user experience and sustain business value.

  • Regulatory Compliance

  • Current State Assessment | Quality System

    • Quality Regulatory Compliance: ISO 9001 Manufacturing, AS9100 Aerospace, ISO/TS 16949 Automotive, ISO 13485 Medical Device, ISO 14971 Risk, FDA Q10 Pharmaceutical, FDA GxP

    • Leadership, Design/Development, Production, Service, Document Control, Training, Auditing, Nonconformity/Corrective Action, Risk Management, Lean Six Sigma DMAIC, Change Control, KPI Dashboards, Continuous Improvement

    • Value-based Approach | Financial & Risk

    • Process Excellence: Tools & Culture

    • Report: Quality System Gap Analysis & Opportunities for Business Value

  • Strategic eQMS Selection

  • Global eQMS Implementation Plan

  • Audit Readiness


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Medical Device | Pharmaceutical | Food & Beverage | Chemical

ISO 13485 | ISO 14971 | FDA Q10 | FDA GxP | ISO 9001

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Aerospace | Automotive | Energy | Manufacturing

ISO 9001 | AS9100 | IATF 16949

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Quality 4.0 SmartFactory | Implementation​​

Momentum SmartFactory advanced Quality 4.0 tools deploy best practices, structure enterprise data flow, automate processes and enable global companies to sustain business value by simplifying the delivery of complex, mission-critical products and services.

  • Automation, Visualization & Data-driven Decision Making

  • Current State Assessment | Quality 4.0 SmartFactory

  • Enterprise KPI Strategy | Design & Visualization

    • Organizational, Departmental, Mission-Critical Processes

    • Customers, WIP, Supply Chain

  • Data Architecture | Quality Performance Data​

    • Data Integrity

      • Data Collection | Structured Detractor Codes

      • iPrecision (Mission-Critical Data Integrity)

    • Data Automation

      • iConnect (Enterprise Automation Dataflow Hub)​

    • Data Reporting & BI Visualization

      • Empowering strategically-aligned low-code Citizen Developers (Process Owners)​

      • Optimizing IT Performance

      • Automating Reports: KPI Thresholds, Certificates of Conformance

  • Global Supply Chain Excellence​

    • Strategic Source Inspection​

      • Qualified Supplier Systems/Processes​

      • Reduced dependency upon 3rd party inspections

    • Efficient ANSI Z1.4 Acceptance Sampling

      • Sustain performance excellence

      • Reduce inspection costs at receiving, WIP, FG and Customer

      • Risk reduction

  • Decision Making | Informed & Proactive 

    • Real-time, Data-driven Performance Monitoring

    • Role-specific KPI Dashboards (Process Owners)

  • Quality 4.0 SmartFactory Implementation Plan

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Continuous Improvement Culture | Implementation​

Quality is more than simply compliance to specifications and regulations. When done right, Quality is aligned with business strategy and inspires continuous improvement culture. Quality is built-in with company-wide process excellence.

  • Quality aligned with Business Strategy

  • Current State Assessment | Continuous Improvement Culture

  • Quality Team

    • Alignment with business strategy | Build and sustain value

    • Supporting cross-functional departments at all levels

    • Roles & Skillsets​

      • Compliance​ & Continuous Improvement

      • Quality BOK

      • Software and data management proficiency

      • Project management proficiency

  • iPMO | Improvement Project Management Office

  • Implementation Plan | Continuous Improvement Culture

  • Build & Sustain Global Excellence​​​

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