Director, GCP/GVP Inspection Readiness & Strategy

Vor Bio

Boston (MA)

On-site

USD 220,000 - 230,000

Full time

4 days ago

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Benefits offered by this job

Health insurance

Flexible paid time off

Parental leave

401(k)

Job summary

Vor Bio is seeking a Director of GCP/GVP Inspection Readiness and Management to provide strategic leadership of global QA programs. You will oversee inspection readiness, regulatory inspections (FDA, MHRA, PMDA, EMA) and internal audits, partnering across Clinical Operations, Pharmacovigilance, Regulatory Affairs, and Quality to sustain compliance and drive improvements.

You will lead responses to observations, develop CAPAs, and communicate metrics and dashboards to leadership, ensuring

Qualifications

Bachelor's degree in life sciences, pharmacy, chemistry, or related field.
Deep understanding of GCP, GVP, ICH guidelines and 21 CFR Part 11.
Experience supporting health authority inspections and readiness.

Responsibilities

Lead the global GCP/GVP Inspection Readiness Program across multiple authorities.
Serve as the primary Inspection Lead for FDA, MHRA, PMDA, EMA inspections.
Provide guidance on inspection readiness and regulatory expectations throughout development.
Develop responses to observations, CAPAs, and audit findings with cross-functional teams.
Create dashboards, KPIs, and risk metrics to track readiness and performance.
Lead internal GCP and GVP audits and drive continual quality improvements.
Partner with stakeholders to ensure timely regulatory interactions and actions.