Lead, Quality Systems

Forge Biologics(5 days ago)

Columbus, OHOnsiteFull TimeSenior$90,000 - $130,000Quality Systems

About this role

Forge Biologics is seeking a Lead for their Quality Systems organization who will oversee and drive continuous improvement in quality management processes supporting GMP operations in a biologics manufacturing environment. The role involves leadership, strategic planning, and compliance to regulatory standards to ensure high-quality production of gene therapies.

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Required Skills

GMP
Change Control
CAPA
Root Cause Analysis
Documentation Control
Investigation
Quality Management System
FDA Regulations
Veeva Vault

Qualifications

Bachelor’s degree in biological sciences, engineering, or a related STEM field
8+ years of GMP Quality Systems experience
2+ years of leadership or supervisory experience

About Forge Biologics

forgebiologics.com

Forge Biologics is a CDMO focused on accelerating gene therapy manufacturing, specializing in high‑yield adeno‑associated virus (AAV) vector production. The company offers end‑to‑end services including process and analytical development, clinical‑to‑commercial cGMP manufacturing at a world‑class facility, and regulatory and supply‑chain support. Clients partner with Forge for scalable AAV capacity, technical expertise, and seamless program support to move therapies faster toward patients.

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