John M. Lewis

About John M. Lewis

Process Engineer with a comprehensive leadership in regulatory compliance, quality training, auditing and SIGMA compiled with exceptional communication skills. Assisting organizations and teams with transformational change, leading to increased compliance, higher quality products, processes and services and minimization of wastes.Specialties: Quality and Process Engineering, Behavioral Observationalist and Behavioral Change Agent, Instructional Design and Training, Compliance Auditing, Project Management and Operational Excellence/Six Sigma methodologies.

Experience

1. Director Operational Excellence - Transformations

   MSD

   Nov 2021 — Present · Upper Gwynedd, PA, US

Education

• The College of New Jersey

  BS, Biology

  1984 — 1987

• Lehigh University

  MSQE, Quality Engineering

  2000 — 2002

• Ocean County College

  AS, Liberal Arts-Biology

  1982 — 1984

Skills

• Technology Transfer
• Leadership
• Life Sciences
• Change Control
• Clinical Development
• Change Management
• 21 Cfr Part 11
• Six Sigma
• Gxp
• Quality Auditing
• Pharmaceutics
• U.s. Food and Drug Administration (Fda)
• Regulatory Affairs
• Lifesciences
• Quality Assurance
• Validation
• U.s. Title 21 Cfr Part 11 Regulation
• R&D
• Microbiology
• Project Management
• Analytical Chemistry
• Oncology
• Management
• Pharmaceutical Sales
• Cross-Functional Team Leadership
• Biotechnology
• Corrective and Preventive Action (Capa)
• Medical Devices
• Capa
• Process Improvement
• CRO
• Quality System
• Training
• Standard Operating Procedure (Sop)
• Strategy
• Pharmaceutical Industry
• Business Process Improvement
• Sop
• Fda
• Clinical Trials