This is an exciting opportunity for an experienced CSV specialist to join a market leading clinical-stage gene therapy company that are developing potentially curative therapies for people suffering from serious diseases. Along with a vast pipeline of preclinical and research activities, they have six clinical programmes in development. They have offices in USA , London, and a large manufacturing facility in Ireland, their geographical footprint provides them with the opportunity to partner with globally leading institutions and attract the best talent across the world.
The Role:
- Implementing, developing, and managing compliance-related electronic systems.
- Ensuring computerised systems are implemented, maintained, and operated in accordance with EU/Annex 11, GAMP, FDA/21 CFR Part 11, Data Integrity GxP requirements and all other applicable regulations.
- Supporting the evaluation of systems and internal audits for processses involving computer systems.
- Ensuring system reviews are performed and upgrades are managed.
- Supporting QMS activities as needed.
- Managing and leading a team with all aspects of the HR process including recruitment, onboarding, mentoring, performance management and employee development.
- Degree educated in Human Health, Sciences or equivalent.
- 5+ years experience with CSV and IT compliance in a GxP environment.
- Experience in implementing, managing and operating IT systems, especially eQMS.
- Knowledge of GxP regulations and policies related to verification and operation of computer systems.
Please note that this role will not offer sponsorship - all candidates must have the RTW in the UK.