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

We are supporting a rapidly scaling, well-funded European biotech developing next-generation cancer therapies targeting areas of high unmet need.

Following significant recent financing and entry into first-in-human clinical development, the company is now entering a critical growth phase. With a highly experienced leadership team and a differentiated scientific strategy, the business is positioned to become a leading player in its field.

To support this next stage, they are seeking an experienced Quality Assurance Manager to play a central role in building and embedding a robust, scalable quality function across the organisation. The role holder will take ownership of the Quality Management System (QMS) across development and operational activities and act as the QA lead across internal functions and external partners. The role will support the organisation as it scales through clinical development and regulatory milestones.

This is a broad and highly visible role, ideal for someone who enjoys working in a dynamic, evolving biotech environment where quality is built collaboratively rather than imposed. We are looking for a hands-on, pragmatic QA professional who thrives in smaller, agile organisations. Strong knowledge of GxP frameworks and ICH guidelines and experience working with outsourced models (CROs, CMOs, CDMOs) is sought. Exposure to clinical-stage development and regulatory submissions (IND/CTA/MAA) would be an advantage. A full brief is available on request