Director GCP/GVP Inspection Readiness and Management Job at Vor Biopharma, Boston, MA

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  • Vor Biopharma
  • Boston, MA

Job Description

Vor Biopharma seeks a Director to lead global Clinical and Pharmacovigilance inspection readiness and management programs. The role involves strategic oversight of regulatory inspections, internal audits, and compliance initiatives across clinical operations, pharmacovigilance, and quality functions to ensure sustained inspection readiness.

Responsibilities

  • Lead development and continuous improvement of global GCP/GVP inspection readiness program
  • Serve as primary Inspection Lead and Host for FDA, MHRA, PMDA, EMA, and other Health Authority inspections
  • Provide leadership and oversight of inspection readiness across clinical, pharmacovigilance, regulatory, data management, and quality functions
  • Establish inspection readiness strategies for CROs, investigator sites, vendors, and outsourced service providers
  • Partner with stakeholders to identify compliance risks, develop mitigation strategies, and drive continuous improvements

Requirements

  • Extensive experience managing GCP/GVP inspection readiness and regulatory inspections
  • Demonstrated leadership across clinical development and pharmacovigilance functions
  • Deep knowledge of FDA, EMA, MHRA, PMDA, and other Health Authority requirements
  • Experience developing and executing risk-based audit programs and CAPA processes
  • Track record managing inspections with multiple global regulatory agencies

Job Tags

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