Due to continued growth, an exciting opportunity has arisen for a Head of Quality to join an innovative biotechnology company in the South of the UK.
The successful candidate will be providing regulatory and GCP expertise, as well as managing the Quality Management System (QMS) and Quality Assurance System.
If you are looking to join an enthusiastic, dedicated team, that are working hard to develop cutting-edge technologies, then this opportunity will be of interest.
- Responsible for all management of the company's quality standards, systems and processes
- Ensure compliance with (GCP), clinical trials regulations and MDD/MDR, keeping in line with company's ISO standards
- Responsible for preparation of audits and regulatory inspections
- Ensure that systems are in place to respond to CAPA’s in a timely manner
- Manage all aspects of the Quality System and SOP life cycle
- Improving the Quality Manual and producing process content on the document management system
- Degree educated in a scientific discipline
- 10 + years’ Quality experience within a medical device/pharmaceutical regulatory environment
- Sound understanding of GCP and clinical trials regulations and compliance requirements
- Knowledge of international Information Security/Privacy requirements (GDPR, ISO27001, HIPPA etc)
- Experience of software validation within a regulated industry i.e. pharmaceutical/medical devices, or other software critical organisation
- Generous employer pension contribution
- Bonus scheme and annual salary review
- 25 days annual leave, increasing up to 28 days
- Life Assurance scheme