Roberta Johnson Email & Phone Number

Proven success managing and improving quality, compliance, training, and document control practices in fast-paced medical environments. Highly skilled at developing and implementing regulatory strategies and processes to gain product approvals worldwide. A leader of people, projects, and overall alignment with core business objectives.Areas of Expertise:  Quality Management  Continuous Improvement Corrective/Preventive Action Root Cause Analysis Organizational Training/GxP Training Programs Business Process Mapping Scorecard development, Tracking and Reporting Policy/Procedure Development Supplier Management Internal/External Compliance Audits Safety/Regulatory Compliance Program and Project Management  Global Regulations including US, EU, JP and ROW regulations in relation to GMP, GCP, GLP, GDP and PV regulations for pharmaceuticals/drugs/biologics/in vitro diagnostics/medical devices ISO Standards (9001, 13485, 14971, 17025, ISO 14001)Industry Designations: Certified Quality Manager/Operation Excellence, American Society for Quality (ASQ) Certified Lead Auditor for 13485, Stat-A-Matrix Certified Biomedical Auditor, American Society for Quality Certified Quality Auditor, American Society for QualityTechnical Skills:Adobe Acrobat | MS Office | MS Project | MS Visio | SharePoint | MasterControl | QMS Systems | Track WiseDocumentum | Alchemy | Livelink | FirstDoc | Veeva | SAP/ERP | Blue Mountain

Listed skills include Fda, Gmp, Quality Assurance, Capa, and 46 others.