Director GCP/GVP Inspection Readiness and Management

About the role

Vor believes 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, the company is silencing upstream survival signals and stopping downstream autoimmune cascades, addressing disease at its root and rewriting what is possible for patients worldwide. Joining Vor means working on a medicine and being 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.

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, CAPAs, and continuous improvement initiatives. Provide strategic leadership across Clinical Operations, Pharmacovigilance, Regulatory Affairs, Medical Affairs, Biometrics, Data Management, Quality, and external partners to promote sustainable compliance, operational excellence, and inspection success throughout the product development lifecycle.

Responsibilities

• Lead the development, implementation, and continuous improvement of the global GCP/GVP Inspection Readiness Program, ensuring a sustained state of inspection readiness across the organization and its external partners.
• Serve as the primary Inspection Lead and Host for FDA BIMO, MHRA, PMDA, EMA, and other Health Authority inspections.
• Provide leadership and oversight for inspection readiness activities across clinical development, pharmacovigilance, regulatory affairs, data