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Lead Qualified Person

4 months ago

Oxford, United Kingdom University of Oxford Full time

We have an exciting opportunity for a Lead Qualified Person (QP) to join our Clinical BioManufacturing Facility (CBF), continuing to support efforts with our well-publicised COVID‑19 vaccine and current and prospective products manufactured on-site in Oxford or by third parties across the world.

Your responsibilities will be as defined in the Code of Practice for Qualified Persons and you will be a named as a QP on the MHRA licence MIA (IMP) 21584 held by the CBF. This is an opportunity for an outstanding QP to join our diverse team, supporting the manufacture of innovative medicines in development at the University of Oxford with the potential to have world-changing impact.

You will be responsible for certifying Investigational Medicinal Products (IMPs) and Advanced Therapy Medicinal Products (ATMPs) for use, ensuring compliance of operations with current and developing regulatory requirements. You will be responsible for completing QP declarations for imported products from India, USA and other countries and for supporting the management of the portfolio of QP activities above, including certifying partial batch manufacture, clinical trial labelling activities and final certification to trial. You will support all CBF activities and provide expert advice on research and manufacturing programmes for Principal Investigators across the University and externally. This role is central and pivotal to the operation and the quality standards of the CBF and is both unusual and highly varied because of the nature and scope of the translational products being manufactured at the CBF.

To be successful in this role, you will hold a degree in chemistry, biology or pharmacy and be a member or higher position of Royal Pharmaceutical Society, the Royal Society of Biology or the Royal Society of Chemistry. You will be named on the ‘Register of Eligible QPs’ of your professional body and be eligible to be a Qualified Person who can be named on the CBF’s MIA (IMP). You will be competent and experienced in managing all aspects of Quality Assurance within a GMP regulated environment, together with having sound knowledge of EU GMP guidelines (EudraLex Volume 4) and evidenced ability to interpret these for early-phase IMPs and ATMPs. You will have managerial or supervisory experience with proven leadership skills, with excellent interpersonal skills with the ability to work with and influence senior members of academic staff.

Applications for this vacancy are to be made online and you will be required to upload a supporting statement and CV as part of your online application. Your supporting statement must explain how you meet each of the selection criteria for the post using examples of your skills and experience.

This position is offered full time on a fixed term contract for 5 years. Please quote 170369 on all correspondence.

The Recruitment for this specialist post is ongoing and we will be continually reviewing applications. Please note that should we fill the vacancy before the closing date, we reserve the right to close this early.

Competitive Salary