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Manufacturing Operations Executive
Turned
Strategic Operations Transformation Partner

From $40M to $130M: Proven FDA Manufacturing Transformation â€‹â€‹â€‹

​​           âœ“ 14+ Years FDA Pharma combination and MedTech devices Manufacturing Leadership

           âœ“ 225% Revenue Growth Through Operational Transformation

           âœ“ 600+ Employee Teams Across International Operations 

           âœ“ $100M+ Partnership Development

Specializing in CDMO Operations, 21 CFR Part 820 Compliance & Post-M&A Integration

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Manufacturing Operations Executive delivering 200% NIAT growth and 5X profitability improvement for FDA-regulated companies through strategic execution and regulatory excellence. Now I help executives like you achieve transformational results.​​

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FORMER GENERAL MANAGER | ISO 13485 Certified Operations | FDA 21 CFR Part 820 Class 2&3 Medical Devices | CDMO | International Manufacturing

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Proven Operational Transformation Results:
 
  • Across operations improvements
  • Process engineering
  • Risk management
  • International product transfers

225%

Revenue Growth

$40M -> $130M

200%

NIAT Growth Delivery

15%

Manufacturing Optimization
Efficiency Gains

5X

Profitability Improvement Year-over-Year

$6.1M

Documented Cost Savings

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Transformation Leader Specializing in Operational Integration and Site Consolidation Excellence​

Delivering $4M+ Operational Synergies Through Systematic Execution & Change Management​​​

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Kathy Otto brings 25+ years of hands-on manufacturing leadership, from chemistry technician to General Manager of a $130M FDA-regulated operation. As a transformation leader specializing in post-merger integration and site consolidation, she delivers operational synergies through systematic program management while protecting customer relationships and employee engagement. Unlike theoretical consultants, she's lived every challenge from the shop floor to the boardroom.

At Phillips Medisize (Molex Company), Kathy led post-acquisition integration of fragmented operations across multiple sites, transforming a $40M facility into a unified $130M powerhouse. Consolidated manufacturing operations, relocated critical equipment, and integrated workforce teams while maintaining zero customer disruption. Delivered 200% NIAT growth and 5X profitability improvements while leading 600+ employees across international operations through systematic change management and operational excellence programs.   .

2025 to Present

Founder & Principal

Otto Strategic Execution LLC​​

Transformation Leader for complex operational consolidations and post-M&A integrations. Specializes in site consolidation management, equipment relocation, change management, and financial synergy realization for PE-backed manufacturing companies.  Delivers systematic execution framework ensuring on-time and on budget transformations while protecting customer revenue and employee engagement.

2017 to 2025

General Manager

Phillips Medisize (Molex Company)

$40M→$130M transformation with 200% NIAT growth. Unified fragmented operations, developed $100M+ Mexico partnership, achieved $4M+ cost savings.

Expertise for Project 

  • Multi-site consolidation and facility optimization

  • Post-merger integration and cultural alignment

  • Change management with retention of key talent

  • Customer communication during operational transitions

  • Governance reporting and financial synergy validation

  • Lean manufacturing and footprint optimization

  • Quality system integration (FDA/regulatory compliance)

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FORMER GENERAL MANAGER | M.S. Technology Management | B.S Chemistry | Lean Manufacturing Certificate | Economic Development Board President 

Strategic Services

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Operational Excellence Implementation
 

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Enterprise Scaling
M&A Integration

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FDA - Regulatory Manufacturing Transformation

  • Lead large-scale transformation initiatives across operations, developing comprehensive strategies aligned with organizational goals

  • Translate high-level vision into tactical execution with measurable KPIs and governance frameworks.

  • SQDC Tier Operating System deployment

  • Lean Manufacturing and Continuous Improvement

  • Drive sustainable business value through efficiency improvements (15% optimization)

  • Complexity reduction, and seamless integration of new capabilities

  • Supply Chain Optimization

  • General Manager coaching and development

  • Manufacturing team building and culture change

  • Cross-functional integration (10+ departments)

  • Execute comprehensive M&A integration strategies ensuring operational continuity and value realization

  • Post - Aquisition performance optimization

  • Facility integration and transformation

  • Cross - border manufacturing partnerships

  • Cultural integration and change management

  • Manage international manufacturing expansion partnerships

  • New product introduction for manufacturers

  • Manufacturing facility transformations and organizational design optimization​

  • 14+ years 21 CFR Part 820 & ISO 13485 Compliance Leadership

  • CDMO operations development and scaling

  • Cleanroom manufacturing - Class 6/7 cleanroom optimization

  • Combination product manufacturing expertise​​​

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Strategic Growth Execution

  • $40M -> $130M scaling methodologies

  • P&L turnaround for manufacturing sites

  • P&L optimization and profitability improvement

  • Manufacturing cost analysis and reduction

  • ROI analysis for manufacturing investments

  • Lead organizational change initiatives during growth periods

  • Developing change management strategies tied to financial models and revenue targets

  • Design optimal organizational structures with clear accountability frameworks and cultural integration

  • New Product Introduction (NPI) programs ($10M+ revenue each)

  • International expansion frameworks

Core Expertise

Comprehensive capabilities that ensure your strategic vision becomes operational reality

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Executive Leadership & Operations

Transformation & Financial Excellence

International Operations & Integration

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  • 25+ years progressive manufacturing leadership

  • P&L ownership: $130M manufacturing operations

  • 600+ employee teams across 10 departments 

  • International manufacturing networks (US/Mexico)

  • Matrix organization influence and collaboration

  • High-performing team development and retention

  • Large-scale business transformation delivery

  • 325% revenue growth ($40M -> $130M)

  • 5X profitability improvement year-over-year

  • $6.1M documented cost savings and margin improvement

  • Advanced financial analysis and ROI optimization

  • International production scale-ups and transfers

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  • International production scale-ups and transfers

  • $100M revenue partnership development (Nogales, Mexico)

  • Manufacturing network integration strategy

  • Cross-cultural team leadership and development

  • Supply chain optimization across borders

  • ROI analysis and investment strategy​

Regulatory Compliance & Quality

Innovation & Market Development

Process Engineering & Excellence

  • FDA Class 2 & 3 medical device manufacturing

  • ISO13485 regulated operations management

  • GMP compliance and regulatory expertise

  • Risk assessment and governance frameworks

  • Quality Managment systems and auditing

  • ​New product introduction and scaling

  • Market launch acceleration strategies

  • Customer lifecycle management excellence

  • Commerical pricing and profitability optmization

  • Revenue operations integration 

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  • Lean manufacturing and continuous improvement

  • 15% manufacturing efficiency optimization

  • Facility layout and workflow optimization

  • SQDC (Safety, Quality, Delivery, Cost) systems

  • Productivity maximization and waste reduction

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Leadership Philosophy

1

Relentless Focus on Outcomes

Drives accountability at all organizational levels with uncompromising commitment to results. Balances genuine care for people with clear focus on driving business performance and excellence.

2

Courageous Decision Making

Challenges assumptions, makes bold recommendations, and drives decisions quickly. Operates with exceptional executive presence to influence and inspire at executive and frontline levels.

3

Builder Mentality

Thrives in environments of ambiguity, complexity, and constant evolution. Solutions-driven and innovative with ability to anticipate challenges and turn decisions into action with urgency.

4

Growth Mindset Excellence

Exhibits resilience and intellectual curiosity with exceptional EQ. Champions ideas, seizes opportunities, and scales winning solutions while maintaining high standards for self and others.

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