Scott Deckebach

About Scott Deckebach

Successful global executive with 40 years of progressive leadership connecting all parts of the organization to create business innovation, profitability, operational efficiency and compliance. Strong expertise in manufacturing, quality assurance and operations, supply chain, engineering and IT. Reputation for Leading and transforming strong customer-driven global functions Excellent business acumen within Pharmaceutical, bio-pharmaceutical and medical device value-chains Deep understanding of manufacturing execution and related big data Broad expertise in compliance for pharmaceutical small and large molecule API, formulation, packaging Quality systems expert – IT, process, equipment, facilities validation and life-cycle management Program and project management, strategic investment planning Training and experience at envisioning, designing and implementing AI and advanced digital solutions Over 40 years of organizational leadership experience: Global Executive and Team Leadership Strategy Business Consulting Project Management Quality Management Regulatory Compliance Technical Design / Implementation Business Continuity Planning Organizational Transformation / Change Mgmt. Information Technology 33 years of pharmaceutical and medical device business experienceFDA / EMEA / cGMP / ISO / EU MDR / DEA & EPA Compliance ISO 13485 Lead Auditor Certified Good Automated Manufacturing Practices (GAMP) LEAN / Six Sigma Process and IT Validation Design of Experiments Quality by Design Process Analytical Technology (PAT) API, pharmaceutical, bio-pharmaceutical and medical device manufacturing operations experience including discrete manufacturing, chemical synthesis, crystallization, separation, distillation, vacuum drying, lyphilization, centrifuging, milling, warehousing, tableting, coating, filling, packaging and asceptic operations

Experience

1. Executive Director of Compliance, Data Governance, Integrity and Advanced Digital Technology

   Lachman Consultant Services

   Mar 2025 — Present · FL, US

   Executive Director in the Compliance Practice at Lachman Consultant Services and head of the Data Integrity and Governance and Advanced Digital Specialty Team. We specialize small and large molecule manufacturing/formulation/filling/tableting/packaging and medical devices, manufacturing/quality/corporate IT systems and computer validation, corporate and site level data governance, manufacturing and laboratory data integrity including detailed data extraction and analysis and new compliance methodologies and organizational design and change management for Pharma 4.0 and use of artificial intelligence and other advanced technologies within a GMP context. Responsible for leading digital innovation solutions both within Lachman and for our clients and related services.

Education

• Colorado School of Mines

  Bachelor of Engineering - BE, Chemical Engineering

• Michigan State University - Eli Broad College of Business

  MBA, Masters of Business Administration

  2003 — 2004

Skills

• Program Management
• Validation
• Executive Management
• Quality Management
• Manufacturing
• Automation
• Pharmaceutical Industry
• Sop
• Fda
• Regulatory Affairs
• Lifesciences
• Process Automation
• Change Management
• Operational Excellence
• Leadership
• 21 Cfr Part 11
• Process Optimization
• CRO
• Change Control
• Technology Transfer
• Process Control
• Regulatory Requirements
• Quality System
• V&V
• Process Simulation
• Project Portfolio Management
• Mes
• Drug Development
• Biopharmaceuticals
• Process Improvement
• Project Planning
• Pharmaceutics
• R&D
• Enterprise Architecture
• Software Documentation
• Sdlc
• Six Sigma
• Gxp
• Gamp
• Computer System Validation