At Blue Earth Diagnostics, our mission is to transform the clinical management of patients with cancer by developing innovative molecular imaging technologies. Our team is made up of industry leaders in the field of radiopharmaceutical development and commercialization. Blue Earth Diagnostics is a dynamic and growing company with an approved product already on the market in the USA and in Europe. Blue Earth Diagnostics is backed by Syncona plc, an investment company listed on the London Stock Exchange.
The company wishes to appoint a Head of Quality Assurance. The position provides an exciting opportunity to play a key role in the company, leading and developing the quality system to establish a high level of compliance in all GxP disciplines across our current and future product portfolio. If you have strong background in Quality & Manufacturing Operations and work in a collaborative and hands-on style, then this opportunity is for you.
Reporting to the Chief Executive Officer, the Head of QA leads the QA function supporting all development and commercial activities to achieve business objectives. Specific responsibilities include:
- Development and management of the Company’s Quality System to ensure compliance with relevant GMP, GDP, GLP, GCP and GPvP guidelines
- Leading quality management reviews
- Managing the recording and investigation of technical product complaints
- In the event of potential or actual product recalls, leading the necessary activities including investigation and external reporting
- Providing quality oversight for drug product contract manufacturing organisations and other GxP material and service providers
- Managing quality aspects for the setup of new drug product manufacturing sites for supply of commercial and development products to company or investigator sponsored clinical trials and commercial supply
- Preparation and review of content for Module 2 and 3 of marketing authorisation applications, variations and supplements
In addition, if qualified, the job holder would be the Responsible Person for the Company’s Wholesale Dealing Authorisation.
Travel within Europe, USA and occasionally other territories will be part of the role occupying up to about 25% of time.
For further information visit http://www.blueearthdiagnostics.com/careers/#HeadQualityAssurance