Lead, QA Operations

Forge Biologics(1 month ago)

Columbus, OhioOnsiteFull TimeManager$116,410 - $154,124 (estimated)Quality Assurance

About this role

The Lead, Quality Assurance Operations supervises and develops junior QA staff and helps oversee cGMP AAV gene therapy manufacturing activities. The role provides expertise in interpreting regulations, agency guidance, and internal policies to ensure product and process compliance. The position is based at Forge Biologics’ Columbus, Ohio facility and supports onsite manufacturing, audits, and continuous improvement initiatives.

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Required Skills

Quality Assurance
Regulatory Compliance
Batch Review
Deviation Management
CAPA Management
Change Control
Document Control
Training Delivery
Team Supervision
Audit Support

+5 more

Qualifications

Bachelor's Degree in Scientific Field or Engineering

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.