Director GCP/GVP Inspection Readiness and Management

Vor Biopharma

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

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Vacancy posted 18 days ago

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