Director GCP/GVP Inspection Readiness and Management

🏢 Vorbiopharma · 📍 Boston, MA 💰 $220,000 - $220,000 / yr
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Position Summary & Responsibilities

Join Us in Tackling Autoimmune Disease at Its Root

At Vor, we believe science can do more than manage symptoms. It can change the course of disease. By advancing telitacicept, a first- and potentially best-in-class dual BAFF/APRIL inhibitor, we are silencing upstream survival signals and stopping downstream autoimmune cascades. Together, we are addressing disease at its root cause and rewriting what is possible for patients worldwide.

When you join Vor, you’re not just working on a medicine. You’re part of a mission to redefine the future of autoimmune care.

Why Work at Vor?

Impact: Contribute directly to a medicine with best-in-disease Phase 3 results in myasthenia gravis and expansion into multiple autoimmune diseases.

Growth: Be part of a rapidly scaling company with opportunities to grow your career in science, clinical development, commercial strategy, and beyond.

Innovation: Work on a platform with potential beyond one indication — a therapy that has already shown consistent results across lupus, IgA nephropathy, and Sjögren’s syndrome.

Belonging: Join a culture where every voice is heard, and where our shared mission unites us across functions and geographies.

 

 

Title: Director, GCP/GVP Inspection Readiness and Management

Position Overview

Provide strategic leadership for Vor's global Clinical and Pharmacovigilance (GCP/GVP) Quality Assurance programs by overseeing inspection readiness, regulatory inspection management, and internal quality audits. Lead the Inspection Readiness and Management Program, serving as the primary Inspection Lead responsible for planning, hosting, facilitating, and directing regulatory inspections conducted by the FDA (BIMO), MHRA, PMDA, EMA, and other global Health Authorities. Lead and execute a risk-based internal GCP/GVP audit program to evaluate compliance with applicable regulations, industry standards, and company procedures.

Partner with leadership and cross-functional stakeholders to maintain a continuous state of inspection readiness, ensure effective execution of regulatory inspections and audits, foster high-quality regulatory interactions, and drive timely responses to inspection and audit observations, C

🎯 Candidate Preparation Guide For Vorbiopharma Applicants

Key Role Competencies & Evaluation Highlights

Key Role Focus:

Evaluating pioneering cell and gene therapy execution with stringent adherence to cellular engineering protocols.

📋 Preparation Priorities (Key Areas to Clarify):
  • 1. Lax attitude toward regulatory compliance or CMC (Chemistry, Manufacturing, and Controls)
  • 2. Treating cellular therapies like traditional small-molecule pharma
  • 3. Inability to manage multi-variable biological data sets
✨ Recommended Role Alignment Hook:

I combine precise cellular engineering with translational rigor to advance next-generation hematopoietic stem cell therapies.

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