QA Manager with ISO 13485 experience – 2 days per week

Enesi Pharma is recruiting a QA Manager for 2 days per week and who will be responsible for maintaining and developing our Quality Management System.

Enesi Pharma is using its ImplaVax® technology to develop a range of innovative needle-free injectable solid dose vaccine products with potential to transform the performance and delivery of vaccines and make a material impact on global healthcare.  Our primary focus is the development of novel solid dose vaccines against a range of infectious and other select diseases, working in partnership with global companies, government agencies and non-governmental organisations.

Clients include the largest vaccine companies, challenger vaccine companies, specialist biotech developers and key governments. We also have several opportunities in animal health.

Enesi Pharma was the winner of the Best New Vaccine Technology/ Platform category in the 2020 Vaccine Industry Excellence Awards at the World Vaccine Congress. This award recognises the outstanding efforts and progress of the Enesi team in applying and leveraging our unique unit solid dose and needle-free ImplaVax® vaccination technology

The QA Manager will be responsible for maintaining and developing our current Quality Management System, including Chairing internal QA Meetings, preparing internal audit schedules, conducting internal audits, co-ordinating non conformity and CAPA activities, writing new procedures as required and reporting to Senior Management at Quality Management Review Meetings.

The QA Manager will also co-ordinate ISO 13485 Audits with external bodies and be responsible for responding to any Audit items.

The QA Manager will develop documentation for Clinical Trials, such as Clinical Operating Procedures, Supplier Quality Agreements, the Master Validation Plan with the CMO and assist with Medical Device File and the CE marking process.

Enesi Pharma offers a great working environment. The facility is based in Oxfordshire with ample parking and excellent transport links.

Requirements

  • Experience of running an ISO 13485 Quality System
  • Experience of US medical device QA systems
  • Experience of drug/device combination products

For more details about the role please contact: hr@enesipharma.com