Senior Director, GxP Quality & Compliance

Immunic Therapeutics; United States; Remoto; USD 150.000 - 190.000; Tempo integral

Resumo da vaga

Immunic Therapeutics seeks an Associate Director/Director of Quality Management Systems (QMS) to own and mature the GxP quality management system as the company moves from late-stage clinical development toward commercialization.

You will lead core QMS processes hands-on, with a small team, and partner with CMC/Manufacturing, Clinical Operations, R&D QA, Regulatory Affairs, IT, Supply Chain and our external CDMOs, CROs and laboratories across the US and Europe.

Qualificações

• Bachelor’s degree in a scientific, engineering or related discipline is required.

Responsabilidades

• Own the GxP quality management system.

Conhecimentos

Quality Assurance

GxP Knowledge

CAPA

Change Control

Deviations

eQMS

CSV/CSA

Regulatory Affairs

Formação

Bachelor’s degree in a scientific, engineering or related discipline

Advanced degree or ASQ certification (CQA, CQE or CMQ/OE) preferred

Ferramentas

eQMS software

LMS

Descrição da vaga

Immunic Therapeutics seeks an Associate Director/Director of Quality Management Systems (QMS) to own and mature the GxP quality management system as the company moves from late-stage clinical development toward commercialization.

You will lead core QMS processes hands-on, with a small team, and partner with CMC/Manufacturing, Clinical Operations, R&D QA, Regulatory Affairs, IT, Supply Chain and our external CDMOs, CROs and laboratories across the US and Europe.