Vandana Arestad

About Vandana Arestad

I am a Versatile Director who delivers high impact strategies, product realization, process optimization within the medical device and pharmaceutical market sectors. My strengths… Skilled in navigating strategic roadmaps, implementing Lean methodologies – continuously improving efficiencies in rapid-growth GMP environments. A collaborative team builder and mentor successful in leading cross-functional groups and evaluating complex quality analytics – consistently surpassing key performance metrics. Efficient site management leader – ensuring full compliance with 21 CFR Part 820, ISO 13485 and ISO 14971 requirements through third-party audits for Class I and Class II medical devices. Strong abilities in negotiating critical programs with C-level management, thought leaders and multiple departments – while delivering enterprise solutions within time and budget. Specialties include: Organizational Improvements | Operational Streamlining | Turn-around Strategy | Platform Redesign | Strategic Planning | Operational Excellence | Multisite Operations | Continuous Improvement | Regulatory Affairs | Process Optimization | Resource Allocation | Relationship Building | Policies and Procedures | Stakeholder Buy-In | Lean Methodology | Class I and II Medical Devices | Validation Processes | Data Analytics | Executive Reporting | Comprehensive Audits | Market Knowledge | Research and Development

Experience

1. Sr Director - Diagnostics and Biodevices Quality Platform Lead

   Zoetis

   May 2020 — Present · Union City, CA, US

Education

• California State University-Sacramento

  Bachelor's Degree, Microbiology and Molecular Biology, Minor in Chemistry

  2000 — 2003

• Northeastern University

  Master of Science (MS), Regulatory Affairs for Drugs, Biologics and Medical Devices

  2014 — 2016

• Purdue Global

  Doctor of Law - JD

Skills

• Quality Assurance
• Biotechnology
• Cross-Functional Team Leadership
• Validation
• Process Validation
• Corrective and Preventive Action (Capa)
• Process Improvement
• Continuous Improvement
• Design Control
• Six Sigma
• Quality Auditing
• Spc
• Lean Manufacturing
• Leadership
• Quality System
• V&V
• Sop
• Fda
• Cqa
• Quality Management
• Product Development
• Quality Control
• Gmp
• Process Control
• U.s. Food and Drug Administration (Fda)
• Manufacturing
• Medical Devices
• Capa
• Iso 13485
• Management
• Root Cause Analysis