A Senior QA Officer role has been created with a pioneering Advanced Therapy organisation in Oxford. This is a fixed-term position to cover upcoming maternity leave, and while it has initially been signed off for 6 months there is a good chance that this will be extended or could lead on to other opportunities within the organisation, given that they are continuing to grow. The equivalent salary would be in the region of £45k - £50k, depending on experience, which can be discussed on application.
Your main place of work will be on the Oxford Science Park. However, the company has a very positive approach to flexibility and you can work on a hybrid basis (to discuss on application).
We are looking for an adaptable, energetic, collaborative, honest and versatile person to join this pioneering company who are developing a new approach to therapeutics for serious diseases, relating especially to the brain and central nervous system.
Your role will include:
- Ongoing maintenance of the QMS and performance of QA activities
- Establishing the processes and mechanisms to ensure that all relevant quality and regulatory requirements are met for quality control testing and contract manufacturing
- Involvement in vendor / supplier qualification
- Ensuring phase-appropriate site compliance with Quality regulations issued by MHRA, FDA and other applicable regulatory bodies
- Driving continuous improvements
- Supporting the development of a Data Integrity framework
- Ensure QA standards are maintained in control of documentation, staff training, facilities and equipment
- Reviewing batch manufacturing and testing records and all associated data in preparation for both primary / secondary packaged material / material for clinical trial supplies
- Supervising and implementing an effective quality audit plan
- Overseeing qualification maintenance work
- Ensuring exceptional standards for document control
- Maintaining and updating SOPs, QMS documents, change controls, root cause analysis and health & safety documents
- Reviewing and updating personnel training plans, carrying out staff training and carrying out quarterly competency assessments
- Ensuring that external documents are distributed and controlled according to processes, and the document status is completed before deadlines to ensure their validity
You will join a small QA team which is developing systems and processes to support the company’s progression into clinical trials in the next couple of years. As such, this will be a fantastic career opportunity, not only to be a part of a growing a cutting-edge therapeutics business but also to develop your skills in QMS maintenance, document control, training, audit-readiness and continuous improvement.
Skills and Experience Required:
- Life science qualification – ideally a degree minimum (preferably a Masters or PhD) in molecular biology, biochemistry, genetics, biotechnology or similar
- A passion for Quality and developing QA / QMS processes
- A knowledge of GMP, GLP and GCP, preferably gained in a small / start-up / preclinical or early phase organisation. Experience from a larger, CMC-focused role would not be as relevant here.
- Excellent communication skills and ability to work with people at all levels
- Proactive, driven, pragmatic, open-minded, emotionally intelligent, positive and respectful approach to your work