Senior Quality Assurance Manager
Nuffield Department of Medicine, Jenner Institute
Clinical BioManufacturing Facility, Old Road, Headington, Oxford, OX3 7JT
Grade 8: Grade 8: £41,526 – £49,553 with a discretionary range to £54,131 per annum
We are seeking a highly motivated Senior Quality Assurance Manager for the Jenner Institute, Clinical BioManufacturing Facility (CBF) ensuring compliance with Good Manufacturing Practice (GMP) and other regulatory requirements. This is an excellent opportunity to work in an academic GMP facility delivering innovative biological products to early phase clinical trials.
You will manage the Quality Assurance Team, reporting to the Head of Quality, and will take the lead in performing delegated duties of the Qualified Person (QP) are performed ensuring prompt batch release of Investigational Medicinal Products, as defined in Annex 16 of the GMP Guide.
In addition, you will be the QA Technical Expert for; Sterile Medicinal Products (GMP Guide Annex 1); Biological Medicinal Products (GMP Guide Annex 2) and/or Advanced Therapy Medicinal Products (GMP Guide Part IV); Investigational Medicinal Products (GMP Guide Annex 13).
You will also manage all day to day operations of the QA team, which currently consists of five members of staff. This will require oversight of the QA review of GMP documentation as well as input into risk assessments, investigations and other Quality Management System (QMS) Documentation. This role will also include undertaking self-inspections and external audits as well as the provision of advice and support for all CBF staff.
You will be educated to degree level in life sciences or engineering. You will be competent and experienced in managing all aspects of Quality Assurance and compliance management procedures within a GMP regulated environment. You will have sound knowledge of GMP guidelines (EudraLex Volume 4), the Medicines for Human Use (Clinical Trials) Regulations 2004 and its amendments, ICH Q9 and Q10 and the ability to interpret these in a non-commercial environment.
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 post is offered full-time on a fixed term contract for 3 years in the first instance and is funded by the Department.
Please quote 151769 on all correspondence. Only applications received before 12.00 noon on Wednesday 21 July 2021 will be considered.