Senior/Principal Quality Assurance Associate
5 days left
- Experience Level
- Experienced (non-manager)
PsiOxus Therapeutics Ltd is an award-winning UK/US development stage biotechnology company developing novel therapeutics for the treatment of cancer, with a focus on immunotherapeutic approaches. We have a first- generation oncolytic virus and three transgene-expressing T-SIGn cancer gene therapy candidates in Phase I/II clinical development and are further developing our innovative platform technology and pipeline of new pre-clinical and research candidates.
We have an exciting new opportunity for a Senior/Principal QA Associate to join our team focusing on supporting the PsiOxus Development (GCP) department. The role will work closely with PsiOxus staff to advise and oversee GCP compliance in the Clinical, Medical Writing and Pharmacovigilance functions in accordance with local and international quality requirements together with review and approval of key quality documents, including SOPs, clinical protocols, key essential documents, and clinical study reports.
Key areas of responsibility will include, but are not limited to:
- Assuring compliance with GCP and other regulatory requirements;
- Managing the Clinical Audit programme;
- Assisting with the management of the PsiOxus Quality Management System (QMS);
- Supporting the External/Supplier audit programme;
- Supporting the Internal audit programme;
- Performing internal audits;
- Performing supplier and clinical site audits;
- Quality Representative on project teams;
- Delivering QMS training for new and existing staff;
We are looking for an enthusiastic and highly organised, self-motivated team player. Applicants should have a BSc or equivalent qualification in a scientific discipline with approximately five years’ industry experience with at least three years in clinical quality assurance in a pharma or biotech organisation. Knowledge of GMP and clinical laboratories will be advantageous. Applicants will have experience of auditing Clinical CROs and performing clinical site audits and have current knowledge of UK, EMA and FDA standards. Good computer proficiency in Excel, PowerPoint and Word is also required.
Applicants will be able to demonstrate a flexible ‘can do’ attitude and good analytical, problem solving and troubleshooting skills. You will be capable of working independently and with the ability to build relationships with a wide range of individuals. Good communication and interpersonal skills are essential together with being able to communicate and interact effectively with staff and other stakeholders at all levels and different cultures.
This is a fantastic opportunity to join our team and become part of something very special. If you would like to apply please ensure you upload a covering letter as well as your CV, explaining to us why you are interested in this position. In return we offer a great working environment, an attractive remuneration package and a range of competitive benefits.
The closing date for applications is 30th April 2021, however applications will be evaluated in the order that they are received. You are therefore encouraged to apply as soon as possible.
Due to the number of applications we receive only shortlisted candidates will be contacted.