Senior QA Lead - Biotech Scale-Up & Compliance

george james ltd; France; Sur place; EUR 70 000 - 110 000; Plein temps

Résumé du poste

George James Ltd is seeking an experienced Quality Assurance Manager to build and embed a robust QMS across development and operations at our European biotech scale-up in France.

The role will lead QA across internal functions and external partners (CROs/CMOs/CDMOs) and support the company through clinical development and regulatory milestones (IND/CTA/MAA). This hands-on professional thrives in a smaller, agile organisation where quality is built collaboratively.

Qualifications

• Hands-on QA in biotech with GxP and ICH knowledge.
• Experience with outsourced models (CROs/CMOs/CDMOs).
• Experience with clinical development and regulatory submissions (IND/CTA/MAA) is a plus.

Responsabilités

• Own and embed the QMS across development and operations.
• Lead QA across internal functions and external partners.
• Support scaling through regulatory milestones.

Description du poste

George James Ltd is seeking an experienced Quality Assurance Manager to build and embed a robust QMS across development and operations at our European biotech scale-up in France.

The role will lead QA across internal functions and external partners (CROs/CMOs/CDMOs) and support the company through clinical development and regulatory milestones (IND/CTA/MAA). This hands-on professional thrives in a smaller, agile organisation where quality is built collaboratively.