Charles Loseby

About Charles Loseby

American Society for Quality (ASQ)- Senior member * American Society for…

Experience

1. Associate Director Quality Systems & Compliance

   Bayer

   Oct 2014 — Present

   Manage a team of 16 direct reports. Responsible for the following Quality Systems and functions- Site Audit program (Internal Audits, Self-Inspections, and Quality Monitoring)- Regulatory Inspections and 3rd Party Audits (Host and facilitator)- Regulatory reporting and market actions (FAR\'s, Recalls, etc.)- Consumer Complaints - Annual Product Review (APR) program - Deviation and CAPA System program business owner (TrackWise)- Change Control program business owner - Documentation System (SOP\'s, Batch Records, Specifications)- System support for Nucleus, SAP, Midas - GMP Training (new employee orientation and Annual GMP Training program)- Site Quality Council lead - Quality Management Systems (implementation and maintenance)- PAI Readiness program

Education

• Rutgers University

  B.S., Biological Sciences

  1983 — 1987

Skills

• Data Analysis
• Technology Transfer
• Problem Solving
• 21 Cfr Part 11
• Quality Auditing
• Pharmaceuticals
• Root Cause Analysis
• Compliance
• Continuous Improvement
• Cgmp
• Anvisa
• Kaizen
• Trackwise
• Process Improvement
• Fda
• Deviation Management
• Change Control
• Validation
• Iso
• Emea
• Quality System
• Quality Management
• Regulatory Requirements
• Lean Sigma
• Change Management
• Impact Assessment
• Complaints Management
• Gmp
• Cleaning Validation
• Process Validation
• Hplc
• Auditing
• Compliance Audits
• Capa
• Quality Systems
• Lean Manufacturing
• Quality by Design
• Lims
• V&V
• Analytical Chemistry