QA Team Leader
Public Health England
The closing date is 26 January 2021
The National Infection Service LaboratoriesResearch department, based at PHE Porton, is the UKs largest capability for the handling of dangerous human pathogens and animal modelling of infectious diseases. The capability is used to understand pathogenesis and undertake pre-clinical development and assessment of new vaccines and therapeutics. The capability is also used to undertake studies in microbiological aerobiology, decontamination and detection, and to develop diagnostic assays for clinical use. Studies are focussed on high priority activities including: Ebola, Zika, Crimean Congo Haemorrhagic Fever, Q Fever, Anthrax, Melioidosis, Clostridium difficile-Associated Disease, Tuberculosis, Monkeypox, Influenza, Pertussis, Meningococcal disease, Group B Streptococcal disease, Legionnaires Disease, Healthcare Acquired Infections, Anti-Microbial Resistance, etc.
Main duties of the job
The Medical Interventions Group (MIG) is involved with delivering projects associated with discovery and evaluation of vaccines and therapeutics. As part of our response to the Covid-19 pandemic and the drive to secure licenced vaccines, PHE have developed and qualified a wild type virus neutralisation assay (WT-VNA) to assess immune responses to SARS-CoV-2 vaccines. We have secured significant funding from the UK Vaccines Task Force (VTF) to establish a new facility to increase the capacity for the WT-VNA to help us meet the global demand for this method.
Public Health England (PHE) is an executive agency of the Department of Health and Social Care providing; strategic leadership, research, advice and support for Government, local authorities and the NHS in protecting and improving the nations health. We offer a benefits package designed to provide an excellent work/life balance, including generous annual leave entitlement, flexible working hours, possibility of working from home and membership of the excellent civil service pension scheme. We are absolutely committed to the development of our staff and offer wide-ranging opportunities for training and professional development
Option 3 External
Open to all external applicants (anyone) from outside the Civil Service (including by definition internal applicants).
- Lead, motivate and manage multidisciplinary teams with responsibility for delivery and maintenance of GxP training, QA Documentation Control and the change control and risk assessment quality processes.
- Ensure the GxP Training system meets the needs of the business and quality system and regulatory requirements
- Ensure the specified elements of the Quality System meet the business need and regulatory requirements.
- Take a lead role in dealing with external and internal customers, setting up, negotiating and agreeing Quality/Technical Agreements, work programmes, reporting progress, dealing with issues to ensure delivery and customer satisfaction
- Set, monitor and report on agreed KPIs for the quality system and identify and implement improvements to the reports as appropriate.
- Educated to degree level in life science or chemistry or equivalent level qualification or significant experience of working at a similar level in a relevant specialist area
- Post-graduate degree in a life/applied science or equivalent
Knowledge & Experience
- Significant experience in interacting with regulatory authorities including MHRA
- Significant experience of management of multidisciplinary teams delivering a variety of services & projects
- Experience of generation, analysis, management & control of GxP documentation, data and records
- Experience of dealing with external and internal customers, setting up, negotiating and agreeing Quality/Technical Agreements, work programmes, reporting progress, dealing with issues to ensure delivery and customer satisfaction
- Experience of working in NSC screening programmes in a quality assurance or related field
- Substantial practical experience of Quality Assurance within a GxP environment
- Practical experience within a biopharmaceutical manufacturing environment
- oExperience of auditing regulated laboratories and test facilities operating in compliance with GLP, GCP and cGMP.
Skills & Capabilities
- Extensive knowledge of specialist areas, acquired through post graduate diploma or equivalent experience or training plus further specialist knowledge or experience to master's level equivalent
- Evidence of post qualifying and continuing professional development
- Must have an understanding of the background to and aims of current healthcare policy and appreciate the implications of this on engagement
- Must be able to prioritise own work effectively and be able to direct activities of others. Experience of managing and motivating a team and reviewing performance of the individuals.
- Must be able to provide and receive highly complex, sensitive or contentious information, negotiate with senior stakeholders on difficult and controversial issues, and present complex and sensitive information to large and influential groups
- Ability to negotiate on difficult and controversial issues including performance and change.
- Adaptability, flexibility and ability to cope with uncertainty and change
- Willing to engage with and learn from peers, other professionals and colleagues in the desire to provide or support the most appropriate interventions
- Demonstrates a strong desire to improve performance and make a difference by focusing on goals.
Analytical and Planning Skills
- Problem solving skills and ability to respond to sudden unexpected demands
- Ability to analyse complex facts and situations and develop a range of options
- Takes decisions on difficult and contentious issues where there may be a number of courses of action.
- Strategic thinking - ability to anticipate and resolve problems before they arise
- Demonstrated capability to plan over short, medium and long-term timeframes and adjust plans and resource requirements accordingly
- Previously responsible for a budget, involved in budget setting and working knowledge of financial processes
- Comprehensive experience of project principles techniques and tools such as Prince 2 and Managing Successful Projects
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Public Health England
PHE Porton Down
Manor Farm Road