Senior/Principal Quality Assurance Associate

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 opportunity for a Senior/Principal QA Associate to join our team focusing on supporting the PsiOxus Translational Medicine laboratory.  The role will work closely with PsiOxus staff to advise and oversee quality compliance in the Translational Medicine (clinical) laboratory in accordance with local and international quality requirements together with review and approval of key quality documents, including SOPs, validation plans/reports, sample analysis plans/reports and analytical methods. 

Key areas of responsibility will include, but are not limited to:

• Assuring compliance with GCP for laboratories and other regulatory requirements;
• Managing the Translational Medicine (clinical) laboratory 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 and supplier/vendor audits;
• 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 higher qualification in a related discipline with approximately 6 years’ industry experience with at least three years in clinical laboratory quality assurance in a pharma or biotech organisation.  Previous experience as an analyst and/or knowledge of analytical methodology/validation is highly desirable.   Knowledge of and experience of equipment qualification is advantageous, as is knowledge of GMP and GLP.  Applicants will have experience of auditing Contract laboratories 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 16 October 2020, 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.