Rebekah Unger

Skills

Enterprise Strategy
SKILLS
Operations Leadership
Manufacturing Transformation Quality Management
Supply Chain Management Digital Platforms
Operational Excellence Regulatory Leadership
Global Program Execution Pharma Franchise Management
Biosurgery NPI MedTech Operations Integration
AI-enabled Supply Chain
Transformation
Machine Learning
Robotics Intelligent Automation
Master Data Management (MDM) ERP Systems
Medical Device Design Optimization Manufacturing Reliability
Governance Models Vendor Optimization
Startup Operations Organizational Strategy
Budget Oversight Vendor Management
Controlled Dissolution Biosurgery Manufacturing
EU MDR Compliance ISO 9001 Compliance
ISO 13485 Compliance 21 CFR Part 820 Compliance
External Manufacturer Management Clean-in-Place (CIP) Processes
Supply Continuity Process Innovation
Mold Design Manufacturing Protocols
Technology Transfers Intelligent Automation
B2B Security Software Parameter Design
Approval Workflows PMO Governance
ROI Analysis Value Realization
Commercialization Adoption Strategies
Value-Based Storytelling Machine Learning
Robotics Intelligent Automation
Data Governance Analytics Governance
Automation Bots Cross-System Integration
Validation Resource Management
FPx Methodology Resource Allocation
Financial Governance P&L Oversight
CAR Approvals Charge-out Controls
T&E Controls Data and Insights Platforms
Vendor Consolidation Pricing Strategies
Customer Visibility Vendor Flex Models
Single-Piece Flow Sourcing Efficiency
Onboarding Cost Reduction ERP Enhancements
Global PPE Sourcing Resource Data Modeling
Procurement Performance Supply Chain Agility
SKU Consolidation CAPA Governance
Quality Remediation Product Recall Management
Engineering Problem-Solving Medical Device Design
Lifecycle Management (LCM) Sustainability Objectives
Procurement Contract Management
Execution Momentum Delivery Continuity
External Manufacturing Oversight Quality Performance
Validation Protocols Vendor Negotiations
Supplier Reliability Throughput Improvement
Quality Management Systems Field Action Recall
QRB Reporting CAPA Reporting
Bottleneck Elimination NPI Management
Cost Optimization Resin CIP
Green Belt Projects Supply
Procurement Organizations Digital Transformation
Regulatory Transformation NDA Change Control
Divestitures Platform Deployment
Manufacturing Productivity Operational Execution
On-Time Delivery Performance Targets
Capital Improvement Inventory Optimization
COGS Improvement Production Scheduling
5S Methodology Inventory Processes
Quality Enhancements Site-Level Quality Programs
FDA 483 Response Program Management
Project Management Plant Start-up
Equipment Procurement Installation
Vendor Management Contract Management
HVAC Systems Compressor Systems
Process Validation Regulatory Compliance
FDA Inspections FDA 483 Observation Responses
Inspection Readiness Regulatory Outcomes
Executive Leadership Cross-functional Team Leadership
Risk Navigation Stakeholder Alignment
Value-Based Storytelling Collaboration
Problem Solving Communication
Negotiation Adaptability
Strategic Planning Decision Making
Team Building Mentoring
Influencing Change Management
Customer Focus Leadership
Business Planning Systems Building
Operational Management Budgeting
Forecasting Strategic Thinking
Execution
SOPs
KPIs
Digital Advertising
Marketing

About

Executive Strategy & Operations Leader driving enterprise-scale transformation
across regulated manufacturing, quality, supply chain, and digital platforms,
delivering multibillion-dollar value through operational excellence, regulatory
leadership, and complex global program execution.