Reference: JVM180626A

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