Quality Management System (QMS) Lead

📋 Description

• Administer, optimize, and maintain the electronic Quality Management System (eQMS) for R&D
• Manage GCP/GLP/GPV document control, including end-to-end lifecycle of SOPs and templates
• Oversee study training matrices and role-based curricula; track training compliance
• Log and facilitate progress of deviations, Quality Issues (QIs), and CAPAs; collect evidence of
• Support audit and inspection readiness, including coordination and record retrieval

🎯 Requirements

• Demonstrated expertise in eQMS administration and GxP document control in pharmaceutical/biotech/CRO
• Hands-on experience with Veeva Vault, TrackWise, MasterControl, or Dot Compliance
• Knowledge of ICH GCP E6, 21 CFR Part 11, and GxP documentation regulations
• Experience managing training matrices, role-based curricula, and qualification records
• Experience with deviations, CAPA lifecycles, and regulatory inspections (FDA, MHRA, EMA)
• Proficiency in MS Office (Word, Excel, SharePoint) and DocuSign Part 11

🎁 Benefits

• Pension (10% employer contribution)
• Private Medical Insurance (including optical and dental)
• Health Cash Plan
• Group Life Assurance (4x basic salary)
• Group Income Protection
• Employee Assistance Program