Kacy Miller

About Kacy Miller

20+ years experienced professional with a demonstrated history of working in the medical device industry and pharmaceutical industry. Extensive background in operations, engineering and quality. Skilled in Medical Devices, Combination Products, Pharmaceuticals, People Management, Continuous Improvement, ISO Standards, and U.S. Food and Drug Administration (FDA).

Experience

1. Global Quality Lead, Operations

   Johnson & Johnson Innovative Medicine

   Mar 2022 — Present

   Responsible to assure that new modality products (vaccines, CAR-T) global releases, schedule and quality contractual agreements and requests are communicated to key stakeholders in Quality as well as global operational teams and assuring that all necessary activity management are in place. Responsible for submitting necessary batch release information from vaccines batches to government and other authorities. Responsible for the New Modalities PMO cross functional team directing the activities for global releases of the products, assuring that improvement activities across the production processes are established and final assurance that cross coordination of releases and delivery schedule.Management of a team responsible for Global Quality System Management Review, Global Insight Management, Business Performance Metrics, and Risk review.

Education

• East Stroudsburg University of Pennsylvania

  BA, Chemistry

  1998 — 2003

• Penn State University

  Bachelor of Science - BS, Chemical Engineering

  2001 — 2003

• Lehigh University

  MBA, Supply Chain

  2007 — 2009

Skills

• Validation
• Six Sigma
• Quality Auditing
• Medical Devices
• Capa
• Quality System
• V&V
• R&D
• Product Development
• Technology Transfer
• Leadership
• Design of Experiments
• Manufacturing
• Process Improvement
• Supply Chain
• Management
• Quality Assurance
• Cross-Functional Team Leadership
• Iso
• Fda
• Materials Management
• Lean Manufacturing
• Continuous Improvement
• Iso 13485
• Gmp