Senior Quality Assurance Associate

National £51,824 – £61,414

Outer £53,812 – £63,252

Inner £55,799 – £65,089

This is a technical role that sits within UKHSA’s award-winning Commercial Directorate, which played a critical role during the COVID-19 pandemic. Truly dynamic, our teams operate at a significant pace in a commercially complex environment to procure a diverse range of goods and services in a highly competitive global market.

UKHSA’s Commercial teams continue to play a central role in priority activity, supporting responses to health threats as they occur, and ensuring enduring, resilient scientific and technical capabilities that secure the UK in the strongest position to protect the public from future threats to health. 

This is an exciting opportunity to work within the Quality Team in Vaccines and Countermeasures Response wider team which includes also the supply of COVID-19 and monkeypox vaccine

The post holder will be in a cross-cutting role based around supply chain management and will be expected to engage with a wide range of stakeholders from global pharmaceutical suppliers to our own storage and national distribution provider. The role will have a reasonable amount of problem-solving and working on Quality Management Systems, and you will need an analytical approach to tasks, as well as delivering at speed.

This technical post will join the Vaccines & Countermeasures Response team, part of the Commercial Directorate within UKHSA. This team is responsible for the procurement and supply functions for vaccines and countermeasures that support the efficient delivery of national immunisation programmes and preparing for effective responses to an influenza pandemic, an accidental or malicious release, and incidents involving certain venoms and toxins, the supply of the COVID-19 vaccine in the UK and beyond (e.g. UK Overseas territories), the monkeypox vaccine and other countermeasures responses.

Vaccines & Countermeasures is responsible for:

• Planning and delivery of national immunisation programmes including the procurement, storage, management and national distribution of vaccines, countermeasures, anti-venoms, anti-toxins and medical devices/consumables.
• National surveillance of most vaccine preventable infections including influenza.
• Effective response to an influenza pandemic, an accidental or malicious release, and incidents involving certain venoms and toxins.
• Maintaining robust immunisation and pandemic/emergency infrastructure and distribution logistics.
• National distribution and clinical use of immunoglobulins and supports or leads outbreak investigations.
• Supply of COVID-19 vaccine to the UK programme and outside the UK
• Support national policy development by
  • Provision of expert advice on the operational feasibility of changes to existing programmes and new programmes, including financial modelling.
  • Evaluation and generation of high-quality data on disease incidence, vaccine coverage, age-specific immunity, vaccine efficacy and safety and analysis of vaccine policy options (with the statistics and modelling department)

Location

The UK Health Security Agency (UKHSA) offers hybrid working – this means that whilst the role will be based in one of our offices, there will be opportunities for an element of working from home. UKHSA have office locations across the UK.

This role can be based at one of our UKHSA offices/locations with opportunities for an element of working from home. You will be asked to express a location preference during the application process. The balance between home and workplace working is to be agreed with the line manager, determined primarily by business needs and in line with departmental policy.

*Please be aware that this role can only be worked from within the UK and not overseas. Relocation expenses are not available.*

The job holder will be required to carry out the following responsibilities, activities and duties:

• To ensure that all operations are compliant with internal procedures and regulatory requirements.
• To support the provision and development of efficient and effective Quality Assurance responsibilities.
• Support and coach the Quality Assurance Associates team
• Expected to act as Deputy Responsible Person once the training period is completed successfully
• Support on writing, reviewing and maintenance of SOPs and Quality Technical Agreements.
• Perform/Review Risk Assessments.
• Participation in the change control process to ensure changes to processes, systems, equipment, and facilities are appropriately assessed and implemented.
• Involvement in supporting GMP/GDP audits, co-ordination of responses and follow up of corrective and preventative actions.
• Involvement in quality issue investigations and agreeing CAPAs.
• Support on the development, implementation and maintenance of the company quality system as required. Identify compliance gaps and adverse trends in quality systems and escalate events requiring immediate action to RP.
• Review validation activities such as equipment and computer systems validations. To engage strong interdepartmental and cross-functional/organizational relationships to drive Quality Systems Requirements (QSRs).
• Involvement in regulatory inspections and internal self-inspections as required. Ensure that storage and distribution and system support arrangements are in place as required.
• Supporting the operational performance of the quality department, ensuring the successful delivery of quality objectives, whilst adhering to regulatory compliance and achieving commercial success.
• Handling of complaints and deviations, including root cause analysis and subsequent CAPA handling.
• Prepare and complete quality documentation and reports regarding quality, and customer-requirements by collecting, analysing and summarising information and trends including failed processes and recalls. This also includes generating the monthly Quality KPIs as required.
• Assessments related to temperature monitoring during transport.
• Examine copies of customer Wholesale Distribution Authorisations, Manufacturing licences and GMP / GDP certificates. Conduct Pre-Certification checks to ensure that all batch documents follow compliance with GMP requirements.
• Involve in the Qualification for approval of suppliers and customers.
• Support on delivering GDP/GMP training to the relevant personnel.
• To ensure that contracts are in place and regularly reviewed for 1) the vaccines and services required for the National Immunisation Programme (including IGs, AVs and ATs) 2) maintenance of stockpiles and other agreements for pandemic flu and emergency preparedness.

The duties/responsibilities listed above describe the post as it is at present and is not intended to be exhaustive. The Job holder is expected to accept reasonable alterations and additional tasks of a similar level that may be necessary.

It is important through your application and Statement of Suitability of no more than 1250 words that you give evidence and examples of proven experience of each of the following criteria:

Essential

• Degree or equivalent in Life Sciences/relevant to post
• A minimum of three years’ experience working within Quality Assurance in the Pharmaceutical sector, including knowledge and experience in GxP 
• Prior experience minimum of 1 year of working to GDP (Good Distribution Practice) standards within the pharmaceutical supply chain sector
• Sound understanding of the UK/ European regulatory framework and current guidelines relating to the manufacture and supply of medicines
• High attention to detail and accuracy
• Strategic thinking – ability to anticipate and resolve problems before they arise
• Excellent verbal and written communication skills with the ability to defend and explain complicated ideas.
• Able to represent UKHSA at meetings and conferences and to chair a number of meetings involving DHSC, NHS England and DA representatives.
• Ability to analyse complex facts and situations, develop a range of options and communicate these effectively to stakeholders at all levels.
• Takes decisions on difficult and contentious issues where there may be a number of courses of action
• Proven experience working in a busy environment with often changing deadlines.

Desirable

• Working experience as Responsible Person or Deputy Responsible Person in a Wholesaler Dealers Licence
• Be a Pharmacist or Pharmacy Technician
• Experience on managing/supervising people
• Knowledge and experience in Good Manufacturing Practice

Working for the UKHSA

We pride ourselves as being an employer of choice, where Everyone Matters promoting equality of opportunity to actively encourage applications from everyone, including groups currently underrepresented in our workforce.

UKHSA ethos is to be an inclusive organisation for all our staff and stakeholders. To create, nurture and sustain an inclusive culture, where differences drive innovative solutions to meet the needs of our workforce and wider communities. We do this through celebrating and protecting differences by removing barriers and promoting equity and equality of opportunity for all.

For more information on the UKHSA please visit: UK Health Security Agency – GOV.UK (www.gov.uk)

Benefits

• Learning and development tailored to your role
• An environment with flexible working options
• A culture encouraging inclusion and diversity
• A Civil Service pension with an average employer contribution of 27%
• Range of health and wellbeing support

Any move to UKHSA from another employer will mean you can no longer access childcare vouchers. This includes moves between government departments. You may however be eligible for other government schemes, including Tax Free Childcare. Determine your eligibility at Childcare Choices , 30 Hours Free Childcare, Tax-Free Childcare and More , Help with Costs , GOV.UK

Job contact :

• Name : Hannah Burton
• Email : UKHSA.recruitment@reed.com

Recruitment team

• Email : UKHSA.recruitment@reed.com