Lead - Quality Assurance

Added
9 days ago
Type
Full time
Salary
Salary not provided

Related skills

gcp change management stakeholder management gmp capa

📋 Description

  • Oversee QA functions across CAPA, Deviations, audits, risk mgmt
  • Ensure GXP compliance: GCP, GVP, GMP, GDocP
  • Lead investigations, CAPA initiation, progress tracking
  • Review and approve CAPA closures; maintain records
  • Escalate issues and manage stakeholder communications
  • Drive governance and trending; Clinical Operations knowledge preferred

🎯 Requirements

  • Quality Assurance; Nonconformance mgmt (CAPA, Deviations, Issues)
  • GXP knowledge: GCP, GVP, GMP, GDocP
  • Initiation, investigation, tracking, and closure of CAPAs
  • Change management, internal/external audits, risk management
  • CAPA effectiveness monitoring and closure reviews
  • Stakeholder management, conflict resolution; Clinical Operations preferred
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