UK Health Security Agency

Senior Quality Officer SEO

Information:

This job is now closed

Job summary

This post is for a Senior Quality Officer in the GxP Quality Assurance Team. The post holder will be part of the independent Quality Assurance which provides support of GxP regulated test facilities.

The Senior Quality Officer role is a very varied and interesting role which involves the provision of functions such as maintaining essential elements of the GxP Quality Management System (including CAPA and non-conformance, quality risk assessment, change control, document control, supplier management etc.), delivery of a variety of training, a variety of audits (facility, support functions, data, process, critical study phases etc.), the review of validation and study documentation, providing compliance advice and the supervision and development of quality officers within the GxP Quality team.

This is a Fixed Term Contract with an end date on 31/03/2024.

Location

Porton Down, Salisbury, Wiltshire, SP4 0JG (on site)

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

Main duties of the job

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

  • Take a lead role in ensuring appropriate quality standards are applied in the GxP Test Facility areas.
  • Assist in ensuring the GxP Training system meets quality, business and regulatory requirements.
  • Take a lead role in maintaining and improving the quality management system (QMS).
  • Take a lead role in ensuring appropriate quality standards are applied in the GxP Test Facility areas and provide specialist GxP quality compliance advice to stakeholders.
  • Take a lead role in setting up and executing an appropriate GxP internal audit programme. Conduct QA reviews/ audits on study data, study records, GxP laboratories, supporting areas and critical suppliers of services and materials.
  • Write and review key quality documents e.g. Quality Reports, Quality Risk Assessments, Technical Agreements, Standard Operating Procedures and Policy documents etc.
  • Manage, review and approve non-conformances, CAPA reports and related investigations, change controls and supplier approval questionnaires.
  • Provide a high level of support to GxP Test Facilities areas, Test Facilities Management and the Quality Team in preparation for, and during customer audits and regulatory inspections.
  • Line manage junior team members in the Quality Team.

About us

Working for the UKHSA

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.
  • 26 days annual leave allowance increasing to 32 days after a 10-year service.

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

Details

Date posted

22 September 2023

Pay scheme

Other

Salary

£38,724 to £44,393 a year Senior Executive Officer

Contract

Fixed term

Duration

5 months

Working pattern

Full-time, Part-time, Job share, Flexible working

Reference number

UKHSA00434

Job locations

Porton Down

Salisbury, Wiltshire

SP4 0JG


Job description

Job responsibilities

STAGE 1 - APPLICATION & SIFT:

You will be required to complete an application form. This will be assessed in line with the advertised essential criteria please do provide evidence of how you meet this.

Your Statement of Suitability (max 1000 words) should outline your skills, experience, and achievements, providing evidence of your suitability for the role, with reference to the essential criteria (outlined in the person specification section).

**Please do not submit your CV, we require you to complete the full application process including a Personal Statement/Statement of Suitability, as outlined below. Please ensure that your Statement of Suitability contains no personal identifiers e.g. name in either the file name or content of the document.**

You will also be asked to provide information within the Employer/Activity history section of the application form. This is equivalent to the information you would provide on a CV, setting out your career history.

If you are successful at this stage, you will progress to an interview.

STAGE 2 INTERVIEW

As part of the process, candidates will be invited to interview which will involve an in-depth discussion of your previous experience and professional competence using the Success Profiles framework.

The Behaviours tested during the interview stage will be:

  • Making Effective Decisions
  • Communicating and Influencing
  • Working Together
  • Delivering at Pace

Expected Timeline:

Advert close: 23:55hrs on 5th October 2023 unfortunately, late applications will not be considered. Once this job has closed, the job advert will no longer be available. You may want to save a copy for your records.

Interviews: W/C 23d October 2023

Please note these dates could be subject to change.

Eligibility Criteria

Open to all external applicants (anyone) from outside the Civil Service (including by definition internal applicants)

Nationality requirements

Appointments to roles within UKHSA will be made in accordance with the Civil Service nationality rules. These can be found athttps://www.gov.uk/government/publications/nationality-rulesThis job is broadly open to the following groups:

  • UK nationals
  • Nationals of Commonwealth countries who have the right to work in the UK
  • Nationals of the Republic of Ireland
  • Nationals from the EU, EEA or Switzerland with settled or pre-settled status or who apply for either status by the deadline of theEuropean Union Settlement Scheme (EUSS)
  • Relevant EU, EEA, Swiss or Turkish nationals working in the Civil Service
  • Relevant EU, EEA, Swiss or Turkish nationals who have built up the right to work in the Civil Service
  • Certain family members of the relevant EU, EEA, Swiss or Turkish nationals

We recruit by merit on the basis of fair and open competition, as outlined in the Civil Service Commission's Recruitment Principles.

The Civil Service embraces diversity and promotes equal opportunities. As such, we run a Disability Confident Scheme (DCS) for candidates with disabilities who meet the minimum selection criteria.

The Civil Service welcomes applications from people who have recently left prison or have an unspent conviction. Read more about prison leaver recruitment.

Security clearance level requirement

Successful candidates must pass a disclosure and barring security check. Successful candidates must meet the security requirements before they can be appointed. The level of security needed is Basic Personnel Security Standard.

A basic check is required.

For posts on UKHSA Civil Service terms and conditions, new entrants to the Civil Service are expected to start on the minimum of the pay band. For existing Civil Servants and roles advertised across government, the rules of transfer apply, i.e., level transfers move on current salary or the pay range minimum, transfers on promotion move to new pay range minimum or receive a 10% increase. Either case is determined by whichever is the highest.

Please Note

This role is to be appointed under Civil Service Terms & Conditions. Full details on the T&Cs are found https://www.ukhsa.reed.com/

Are you already a civil servant, or employed by a Civil Service Commission accredited public body? Please state home department on your application form.

Do you meet the nationality requirements for this post? https://www.ukhsa.reed.com/

The law requires that selection for appointment to the Civil Service is on merit on the basis of fair and open competition as outlined in the Civil Service Commission's Recruitment Principles. If you feel your application has not been treated in accordance with the Recruitment Principles, and you wish to make a complaint, in the first instance, you should contact UKHSA Public Accountability Unit via email: Complaints1@ukhsa.gov.uk. If you are not satisfied with the response you receive from the Department, you can contact the Civil Service Commission: Visit the Civil Service Commission website.

Job description

Job responsibilities

STAGE 1 - APPLICATION & SIFT:

You will be required to complete an application form. This will be assessed in line with the advertised essential criteria please do provide evidence of how you meet this.

Your Statement of Suitability (max 1000 words) should outline your skills, experience, and achievements, providing evidence of your suitability for the role, with reference to the essential criteria (outlined in the person specification section).

**Please do not submit your CV, we require you to complete the full application process including a Personal Statement/Statement of Suitability, as outlined below. Please ensure that your Statement of Suitability contains no personal identifiers e.g. name in either the file name or content of the document.**

You will also be asked to provide information within the Employer/Activity history section of the application form. This is equivalent to the information you would provide on a CV, setting out your career history.

If you are successful at this stage, you will progress to an interview.

STAGE 2 INTERVIEW

As part of the process, candidates will be invited to interview which will involve an in-depth discussion of your previous experience and professional competence using the Success Profiles framework.

The Behaviours tested during the interview stage will be:

  • Making Effective Decisions
  • Communicating and Influencing
  • Working Together
  • Delivering at Pace

Expected Timeline:

Advert close: 23:55hrs on 5th October 2023 unfortunately, late applications will not be considered. Once this job has closed, the job advert will no longer be available. You may want to save a copy for your records.

Interviews: W/C 23d October 2023

Please note these dates could be subject to change.

Eligibility Criteria

Open to all external applicants (anyone) from outside the Civil Service (including by definition internal applicants)

Nationality requirements

Appointments to roles within UKHSA will be made in accordance with the Civil Service nationality rules. These can be found athttps://www.gov.uk/government/publications/nationality-rulesThis job is broadly open to the following groups:

  • UK nationals
  • Nationals of Commonwealth countries who have the right to work in the UK
  • Nationals of the Republic of Ireland
  • Nationals from the EU, EEA or Switzerland with settled or pre-settled status or who apply for either status by the deadline of theEuropean Union Settlement Scheme (EUSS)
  • Relevant EU, EEA, Swiss or Turkish nationals working in the Civil Service
  • Relevant EU, EEA, Swiss or Turkish nationals who have built up the right to work in the Civil Service
  • Certain family members of the relevant EU, EEA, Swiss or Turkish nationals

We recruit by merit on the basis of fair and open competition, as outlined in the Civil Service Commission's Recruitment Principles.

The Civil Service embraces diversity and promotes equal opportunities. As such, we run a Disability Confident Scheme (DCS) for candidates with disabilities who meet the minimum selection criteria.

The Civil Service welcomes applications from people who have recently left prison or have an unspent conviction. Read more about prison leaver recruitment.

Security clearance level requirement

Successful candidates must pass a disclosure and barring security check. Successful candidates must meet the security requirements before they can be appointed. The level of security needed is Basic Personnel Security Standard.

A basic check is required.

For posts on UKHSA Civil Service terms and conditions, new entrants to the Civil Service are expected to start on the minimum of the pay band. For existing Civil Servants and roles advertised across government, the rules of transfer apply, i.e., level transfers move on current salary or the pay range minimum, transfers on promotion move to new pay range minimum or receive a 10% increase. Either case is determined by whichever is the highest.

Please Note

This role is to be appointed under Civil Service Terms & Conditions. Full details on the T&Cs are found https://www.ukhsa.reed.com/

Are you already a civil servant, or employed by a Civil Service Commission accredited public body? Please state home department on your application form.

Do you meet the nationality requirements for this post? https://www.ukhsa.reed.com/

The law requires that selection for appointment to the Civil Service is on merit on the basis of fair and open competition as outlined in the Civil Service Commission's Recruitment Principles. If you feel your application has not been treated in accordance with the Recruitment Principles, and you wish to make a complaint, in the first instance, you should contact UKHSA Public Accountability Unit via email: Complaints1@ukhsa.gov.uk. If you are not satisfied with the response you receive from the Department, you can contact the Civil Service Commission: Visit the Civil Service Commission website.

Person Specification

Qualifications

Essential

  • Educated to MSc and several years' experience or Degree and substantial relevant experience (in relevant subject area).

Knowledge and Experience

Essential

  • Experience of having worked within a regulated environment (GMP, GCP, GLP).
  • Good knowledge and preferably practical familiarity of laboratory techniques.
  • Good knowledge of GxP Data Integrity requirements.
  • Experience in leading, conducting and reporting GxP audits.
  • Experience in developing/ managing/ maintaining Quality Management Systems relevant to this post (e.g. CAPA, change control, quality risk assessment, training, document control).

Desirable

  • Experience of leading projects and/or teams.
  • Basic understanding of GxP equipment, computer systems and method validation requirements.

Skills and Capabilities

Essential

  • Clear communicator with excellent writing, report writing and presentation skills; capable of constructing and delivering clear ideas and concepts concisely and accurately for diverse audiences
  • Skills for communication on complex matters and difficult situations, requiring persuasion and influence.
  • Skills for nurturing key relationships and maintaining networks.
  • Ability to analyse and interpret information, pre-empt and evaluate issues, and recommend and appropriate course of action.
  • Problem solving skills and ability to respond to sudden unexpected demands.
  • Takes decisions on difficult and contentious issues where they may be a number of courses of action.
  • Attention to detail combined with the ability to extract key messages from complex analysis.
  • Previous experience in planning and scheduling audits.
  • Ability to engender trust and confidence and demonstrate integrity in the provision of advice and support.
  • Proven ability in training junior staff.
  • Ability to work on own initiative and organise own workload without supervision working to tight and often changing timescales
  • Ability to work on own initiative in a supportive manner within a team environment
Person Specification

Qualifications

Essential

  • Educated to MSc and several years' experience or Degree and substantial relevant experience (in relevant subject area).

Knowledge and Experience

Essential

  • Experience of having worked within a regulated environment (GMP, GCP, GLP).
  • Good knowledge and preferably practical familiarity of laboratory techniques.
  • Good knowledge of GxP Data Integrity requirements.
  • Experience in leading, conducting and reporting GxP audits.
  • Experience in developing/ managing/ maintaining Quality Management Systems relevant to this post (e.g. CAPA, change control, quality risk assessment, training, document control).

Desirable

  • Experience of leading projects and/or teams.
  • Basic understanding of GxP equipment, computer systems and method validation requirements.

Skills and Capabilities

Essential

  • Clear communicator with excellent writing, report writing and presentation skills; capable of constructing and delivering clear ideas and concepts concisely and accurately for diverse audiences
  • Skills for communication on complex matters and difficult situations, requiring persuasion and influence.
  • Skills for nurturing key relationships and maintaining networks.
  • Ability to analyse and interpret information, pre-empt and evaluate issues, and recommend and appropriate course of action.
  • Problem solving skills and ability to respond to sudden unexpected demands.
  • Takes decisions on difficult and contentious issues where they may be a number of courses of action.
  • Attention to detail combined with the ability to extract key messages from complex analysis.
  • Previous experience in planning and scheduling audits.
  • Ability to engender trust and confidence and demonstrate integrity in the provision of advice and support.
  • Proven ability in training junior staff.
  • Ability to work on own initiative and organise own workload without supervision working to tight and often changing timescales
  • Ability to work on own initiative in a supportive manner within a team environment

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.

Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

Additional information

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.

Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

Employer details

Employer name

UK Health Security Agency

Address

Porton Down

Salisbury, Wiltshire

SP4 0JG


Employer's website

https://www.gov.uk/government/organisations/uk-health-security-agency (Opens in a new tab)

Employer details

Employer name

UK Health Security Agency

Address

Porton Down

Salisbury, Wiltshire

SP4 0JG


Employer's website

https://www.gov.uk/government/organisations/uk-health-security-agency (Opens in a new tab)

Employer contact details

For questions about the job, contact:

RPO Talent Specialist

Nicoleta Enciu

UKHSA.Recruitment@reed.com

Details

Date posted

22 September 2023

Pay scheme

Other

Salary

£38,724 to £44,393 a year Senior Executive Officer

Contract

Fixed term

Duration

5 months

Working pattern

Full-time, Part-time, Job share, Flexible working

Reference number

UKHSA00434

Job locations

Porton Down

Salisbury, Wiltshire

SP4 0JG


Supporting documents

Privacy notice

UK Health Security Agency's privacy notice (opens in a new tab)