Kevin D Wojtas

About Kevin D Wojtas

I am a Quality and Digital Transformation leader who has spent my career helping organizations strengthen compliance, modernize systems, and build capabilities that raise performance across entire manufacturing networks. With experience that began on the shop floor and grew through validation, metrology, CSV, Data Integrity, and global compliance leadership, I bring a uniquely end‑to‑end perspective on how quality, digital, and operations intersect.I am known for diagnosing complex problems, stabilizing broken processes, and building sustainable operating models that work in real‑world, highly regulated environments. My work has spanned enterprise Data Integrity programs, global CSV governance, regulatory intelligence, Annex 1 integration, and now digital transformation across Takeda’s Biologics Operating Unit.I lead through partnership — bringing together Quality, Digital, IT, Manufacturing, and site teams to align priorities, reduce risk, and accelerate value. Whether modernizing digital workflows, improving data governance, strengthening inspection readiness, or developing talent across large networks, my goal is always the same: build systems and capabilities that last.Today, I focus on helping global biologics sites identify and prioritize high‑value improvements through structured diagnostics, digital assessment, and process redesign. I am passionate about transforming quality organizations into modern, data‑driven, digital‑enabled teams equipped to support the next generation of biologics manufacturing.I thrive where compliance, digital innovation, and enterprise transformation meet — and where thoughtful leadership can unlock meaningful and sustainable change.

Experience

1. Head, Quality Digital and Innovation - Biologics Operating Unit

   Takeda

   Sep 2025 — Present · Lexington, MA, US

   Lead digital quality strategy and transformation across the Biologics Operating Unit, strengthening digital adoption, process capability, and regulatory readiness across global manufacturing sites.I diagnose system, process, and digital adoption gaps across the Biologics network, working with site and network leadership to identify, quantify, and prioritize improvement opportunities. This includes assessing quality system performance, data integrity risks, digital maturity, and workflow inefficiencies across QC, QA, and manufacturing operations.I serve as the global Quality Digital partner for the diagnostic phase of major site‑transformation programs at two biologics manufacturing sites. In this role, I lead structured assessments using process mapping, data analysis, and stakeholder interviews to uncover improvement opportunities and define value‑driven transformation portfolios. This work strengthens site readiness for digital solutions and supports sustainable capability building.I collaborate with DD & T, Quality, and manufacturing partners to align digital execution with operational priorities, regulatory requirements, and risk‑based decision‑making. I evaluate digital solutions, automation opportunities, and process‑enhancement pathways to drive efficiency, reduce manual burden, and improve quality outcomes.I also support organizational capability building by clarifying roles, maturing governance, and enabling more consistent adoption of digital technologies across the Biologics Operating Unit. My work advances Takeda’s digital quality strategy while ensuring changes are scalable, compliant, and aligned with long‑term manufacturing and quality goals.This role continues to build on my experience in global quality systems, digital transformation, and enterprise capability development — enabling me to drive meaningful, sustained change across complex manufacturing environments.

Education

• Illinois State University

  BS, Mathematics

  1988 — 1992

Skills

• Process Improvement
• Computer System Validation
• 21 Cfr Part 11
• Software Quality Assurance
• Electronic Signatures
• Change Management
• Software
• Validation
• Sdlc
• Testing
• Calibration
• Cross-Functional Team Leadership
• Root Cause Analysis
• Quality Assurance
• Fda
• Change Control
• Medical Devices
• Gxp
• Gmp
• Quality System
• Sop
• Gamp
• Iso 13485
• Project Management
• V&V
• Quality Control
• Capa
• Six Sigma
• Quality Auditing
• Software Documentation
• Risk Management
• Regulatory Requirements
• Process and Equipment Validation
• Leadership
• Continuous Improvement
• Quality Management
• Pharmaceutical Industry
• R&D
• Design Control
• Glp