Head of Quality Assurance

We are currently looking for a cross functional Head of Quality Assurance to join a leading start up Cell and Gene company based in the London area. As the Head of Quality Assurance. you will be responsible for the implementation of their Quality Management System (QMS) from scratch, dealing with documentation, SOP’s and the setting up of their QA function.

Your duties as the Head of Quality Assurance will be varied however the key duties and responsibilities are as follows:

1. As Head of Quality Assurance, you will implement a Quality Management System of your choice from scratch, writing SOP’s, dealing with documentation

2. You will be involved from early stage drug development to the regulatory and manufacturing stages, scaling to be ready for a Phase I study in the lab.

3. You will also deal with daily QA duties such as, dealing with CAPA’s, change controls, deviations, risk assessments and any potential customer complaints.

To be successful in your application to this exciting opportunity as the Head of Quality Assurance, we are looking to identify the following on your profile and past history:

1. You will have a relevant degree in a Life sciences related subject or equivalent.

2. The successful candidate will have proven industry experience in the implementation of QMS, setting up of a QA function and managing a QA team.

3. A working knowledge and practical experience with the drug development life cycle from early research stages through to the manufacturing, as well as any potential cell and gene experience.

Key Words: QA | Quality Assurance | Quality | QMS | QA function | Cell and Gene | Pharmaceutical | GMP | SOP’s | CAPA’s | Change Controls | Risk Assessment