Director, Global GCP/GVP Inspection Readiness

Vor-Bio; Boston (MA); On-site; USD 220,000 - 230,000; Full time

Benefits offered by this job

Health coverage

Flexible paid time off

Parental leave

401(k)

Job summary

Vor Bio in Boston, MA seeks a Director, GCP/GVP Inspection Readiness and Management to provide strategic leadership for global QA programs, overseeing inspection readiness, regulatory inspections (FDA, EMA, PMDA) and internal audits.

You will partner across Clinical Ops, Pharmacovigilance, Regulatory Affairs, and QA to ensure continuous readiness, drive CAPAs, and lead responses to observations. This senior role requires 12+ years in pharma, strong communication, and travel 25-50%.

Qualifications

• Minimum 12 years in regulated pharma/biotech with 5+ years in leadership.
• Deep knowledge of GCP/GVP, ICH, 21 CFR Part 11, ALCOA+ and inspections.
• Experience supporting multiple health authority inspections (FDA, EMA, PMDA, MHRA).

Responsibilities

• Lead global GCP/GVP Inspection Readiness program and host inspections.
• Provide leadership across Clinical Ops, PV, Regulatory, Data Management, and QA.
• Develop responses to inspection findings, CAPAs, and continuous quality improvements.
• Establish inspection readiness strategies for CROs, sites, vendors.
• Develop dashboards and KPIs to monitor inspection readiness.

Skills

Leadership

Inspection readiness

GCP/GVP expertise

Regulatory inspections

Cross-functional leadership

Education

Bachelor's degree in life sciences or related field

Job description

Vor Bio in Boston, MA seeks a Director, GCP/GVP Inspection Readiness and Management to provide strategic leadership for global QA programs, overseeing inspection readiness, regulatory inspections (FDA, EMA, PMDA) and internal audits.

You will partner across Clinical Ops, Pharmacovigilance, Regulatory Affairs, and QA to ensure continuous readiness, drive CAPAs, and lead responses to observations. This senior role requires 12+ years in pharma, strong communication, and travel 25-50%.