Global Document Management Manager

Job Summary

Supporting the management of global, regional, and local procedural documents, the full-time Global Document Management Manager will oversee the development and improvement of the Quality System, assist with GxP inspections, and manage Standard Operating Procedures while working remotely.

Key Responsibilities

• Support the development, implementation, and continuous improvement of the Quality System across GxP-related functional areas
• Assist in the preparation for GxP inspections and responses to Regulatory Authorities
• Manage the development and revision of global Standard Operating Procedures and Working Practices to ensure regulatory compliance

Required Qualifications

• Degree in natural science or equivalent experience
• 4+ years of relevant experience in clinical, industry, or Regulatory Authority settings, preferably in Quality Management
• Advanced knowledge of regulations and guidance documents related to Pharmacovigilance, Clinical Development, and Regulatory Affairs
• Experience in Monitoring, Quality Assurance, and Good Clinical Practices
• Proficiency in MS Office and understanding of change management processes