Quality Assurance Associate

Full Time
1 week ago

PsiOxus is a clinical-stage company redefining therapies for solid tumors to cure cancer patients. Our clinically validated T-SIGn vector platform can deliver multiple therapeutic payloads to drive sustained reprogramming of the tumor micro-environment in both primary and metastatic sites thus enabling a new paradigm for future cancer care. We have a rapidly expanding pipeline of novel monotherapy and combination products to dramatically improve outcomes for patients with cancer.

We have active collaborations in the UK & USA, including Bristol Myers Squibb, bluebird bio (Boston) on T-SIGn combinations with CAR-T cell therapy and with the Parker Institute for Immunotherapy (San Francisco).

The main purpose of this role is to support the day-to-day management of the PsiOxus Quality Management System and provide Quality Assurance support to staff.  This role focusses on supporting the PsiOxus Translational Medicine (GxP) laboratory and will work closely with colleagues to advise and oversee quality compliance in accordance with local and international quality requirements.  You will review and approve key quality documents, including SOPs, validation plans/reports, sample analysis plans/reports and analytical methods.  We are ideally looking for someone to be in the office 2-3 days per week, flexibility can be agreed. This is a full-time permanent role.

Responsibilities will include:

  • Assuring compliance with GCP for laboratories and other regulatory requirements.
  • Managing the 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;
  • Any other quality related duties, as delegated to support the business.

We are looking for an enthusiastic and highly organised, self-motivated team player.  Applicants should have a Batchelor’s degree or higher qualification in a related discipline with a minimum of three years’ industry experience with at least two years in clinical laboratory quality assurance in a pharma or biotech organisation.  Previous experience as an analyst and/or knowledge of analytical methodology, knowledge of GCP for laboratories and knowledge of UK, EMA and FDA standards is mandatory. Experience of equipment qualification auditing, auditing Contract laboratories and vendors and knowledge of GMP, GCP and GLP is advantageous.  Good computer proficiency in MS Office including 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 to interact effectively with staff and other stakeholders at all levels and from different cultures.

This is a fantastic opportunity to join our team and have an impact on the health and well-being of people with cancer. In return we'll help you build a career that you can feel passionate about.  If you would like to apply please visit our website and ensure you upload a covering letter and CV, explaining 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 including:

  • Competitive salary and discretionary bonus scheme
  • Private medical insurance including optical and dental
  • Critical illness cover
  • Income protection
  • Life Insurance
  • Pension
  • Various offers via Perkbox including Nuffield annual health assessments
  • 25 days holiday and the option to buy 5 additional days
  • On-site parking
  • Flexible working

As part of our background screening process, we conduct Basic DBS checks on successful candidates.

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.

PsiOxus Therapeutics
4-10 the quadrant
Barton Lane