ATTC Quality & Standards Manager
An amazing opportunity has arisen for an ATTC Quality & Standards Manager to join a pharmaceutical organisation in London. This role is dedicated to delivering standard initiatives using efficient and innovative solutions.
- Help to develop Companion Diagnostics standards to accelerate the adoption of ATMP, using exemplar products to test the system.
- Work with international bodies to develop international standards suitable for use in the NHS and globally.
- Work with Regulators (MHRA, HTA, NICE) to ensure the work meets regulatory requirements
- Engage with existing ATMP manufacturers, supporting industry partners and the NHS to identify opportunities and challenges and jointly agree way forward
- Develop strategies for optimisation of harmonisation of practices to appropriate quality and regulatory standards
- Assess potential for cross-linking and interoperability with other relevant data sources to address evidence gaps / validate quality of evidence
- Develop and implement a 20-month workplan than enables the implementation of the above optimisation strategies
Skills and Requirements
- Degree level educated in a Life Science or related discipline.
- 5+ years' experience of relevant ATMP development and supply from a quality or manufacturing viewpoint.
- Understanding of the quality and regulatory requirements for ATMP manufacture and supply
- Experience of supply of Medical Products into the NHS, either from starting material procurement, clinical trial and marketed product delivery
- Experience in running multi stakeholder projects
- Experience of PowerPoint presentations and generating Executive/Board reports
- Flexible and pragmatic, able to learn quickly and respond to project needs and priorities
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Josh Godden on +44 203 854 0101 or upload your CV on our website - www.proclinical.com/send-cv