Steven Zera
Global Operations and Quality | Operational Excellence | Digital Transformation | Program Management (PMO) Leader
- Role
- Independent Consultant Contractor at Valuepro Llc
- Location
- Raleigh-Durham-Chapel Hill, NC, US
- LinkedIn followers
- 500 followers
About Steven Zera
Global Operational Excellence and Transformation Leader with 20+ years driving enterprise-wide performance improvements in Medical Device, Pharmaceutical, and Life Sciences manufacturing. Proven success in leading multi-site transformations, acquisitions/integrations, contract manufacturing/supplier excellence, digital manufacturing initiatives, and quality culture programs that deliver double-digit cost reductions, yield improvements, and sustainable compliance excellence. Recognized for building global strategies, mobilizing cross-functional teams, and aligning operations with business growth objectives in FDA- and GMP-regulated environments. Key Skills: Manufacturing & Operations: Certified Lean Leader, 6-sigma Black / Green Belt, Contract Manufacturing (CMO), Medical Devices (Class 1,2,3), Pharmaceuticals (API, Parenteral), Life Sciences, Lean Transformations, Process Development, Operational Quality Assessments, Supply Chain Management, Engineering Department Head, CMMS, ERP, Agile, Matrix Organization Leadership.Strategy & Financial Analysis: Policy Deployment, Hoshin Kanri, Costing / Budgeting, Financial Acumen, Cost Reduction Strategies, Strategic Planning, Financial Analysis, Strategic OperationsData & Technology:Digital Transformation, Industry 4.0, Data Analytics & Visualization, Artificial Intelligence, Digital Twin, Digital Thread, Manufacturing Execution Systems (MES), Performance Management, Statistical Analysis, Minitab, Smartsheet, Published Advanced Manufacturing Research Study/Survey and Advanced Technology Use Cases.Project & Program Management: Certified Project Management Professional (PMP #17•••77), Program / Project Management, PMO Leadership, MS Project, Capital (CAPEX) Planning.Quality Management:CAPA, Post Market Vigilance, LIMS, Risk Management, Validation / Verification, Production & Process Controls, Supplier Quality, Quality Culture Transformations, Culture Assessments, GMP Compliance, QMS, Quality Assurance, Quality Control, Digital QMS, FDA Collaboration, Trackwise, Agile.
Experience
Independent Consultant Contractor
Mar 2025 — Present · Raleigh, NC, US
Providing strategic and program/project-level support engagements in Operational Excellence, Lean transformations, and Digital Manufacturing adoption for Medical Device, Pharmceautical and Life Science manufacturers by- Driving readiness assessments and program design to enable local or enterprise-wide harmonization, compliance, and scalability- Providing Program/Project Management services to drive Operational Excellence and Operational Quality improvement initiatives- Providing SME support for FDA driven Quality Management Maturity (QMM) program within the Pharmaceutical/Drug industry
Education
Virginia Tech
BS
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