Charles Yourdon

About Charles Yourdon

Quality leader with over 30 years of pharmaceutical/biological/CMO experience, primarily…

Experience

1. Global Head of Document Management

   Boehringer Ingelheim

   Jun 2018 — Present

   Report to Global Head of Quality Services based in Germany; serve as a people manager, matrix manager and cost center manager- Ensure the definition, deployment and maintenance of Quality Systems across the Boehringer Ingelheim Animal Health Business Unit (>$4.5B business with around employees across 16 Manufacturing Sites, 14 R&D Sites, Third Party Management with >120 external partners) in accordance with pharmaceutical regulatory requirements and company Corporate Requirements- Ensure implementation of the documentation structure supporting the Quality system covering the full lifecycle of company products as the Global Process Owner for Animal Health- Represent Animal Health in corporate Document Management Governance Bodies- Manage a team of administrators and document coordinators providing expertise, training, support to Site managers, System Owners, Functional Leaders, etc. Team members are based in various locations including Germany and Philippines- Work closely with the Learning Management System team (SAP SuccessFactors)- Serve as Animal Health Functional Project Lead to implement and migrate to a new document management system (Veeva Vault QualityDocs) for Corporate, Divisional and Regional/Local Directives, SOPs, Work Instructions, Forms, Guidance, etc. Application testing is performed using HP ALM following Agile approach. Enhancement requests managed via Jira- Integrate and harmonize business processes through entire Animal Business Unit (AUS/NZ, China, Italy, UK, France, Germany, Netherlands, Brazil, Mexico, US). Provide instructor led training and application support for sites and functions.

Skills

• Trackwise
• Risk Assessment
• Software Documentation
• Clinical Development
• Gxp
• Regulatory Affairs
• Change Control
• Software Validation
• Cleaning Validation
• Sop
• Quality Systems
• Lims
• Documentation
• Biotechnology
• Chromatography
• Pharmaceutical Industry
• 21 Cfr Part 11
• Technical Writing
• Pharmaceutics
• Change Management
• Microsoft Office
• Glp
• Erp
• Biopharmaceuticals
• Gamp
• Project Management
• E-Learning
• Compliance
• Auditing
• Cgmp
• Quality Auditing
• Sdlc
• Capa
• Pharmaceuticals
• Process Validation
• Technology Transfer
• Gmp
• Automation
• Hplc
• Validation