Job summary
The Culture Collections Quality Assurance & Regulatory Manager will report directly to the Head of Culture Collections and serve as a member of the Culture Collections senior management team with responsibility for defining the strategy for, and managing, the overall Culture Collections quality assurance and regulatory strategy so that it delivers its agreed goals.
The management and application of the Culture Collections quality systems that assure product quality and batch release of product into saleable stock. To ensure that Culture Collections operations and products comply with external standards and regulations.
The Culture Collections Quality Team also have responsibility for managing and coordination of ISO 9001:2015 compliance on the Porton site, as applicable to Research, Culture Collections, and applied support functions.
Location
UKHSA Porton Down Office - This is an office-based role.
*Please be aware that this role can only be worked from within the UK and not overseas. Relocation expenses are not available. *
Working Pattern - Full Time, Part Time, Job Share, Flexible Working.
Main duties of the job
Responsibilities section:
As the Lead Quality Assurance Manager your main responsibilities will include:
The job holder will be required to carry out the following responsibilities, activities, and duties:
- To manage and represent Quality Assurance in the Culture Collections business.
- To retain certification of ISO 9001:2015 on the Porton site to the current scope.
- Interact with other Culture Collections Senior Managers to deliver quality goals.
- Be responsible for maintenance of UKAS accreditation to ISO 17025:2017 in all relevant areas and collaborate with Operational leads to ensure the scope is extended as required.
- Managing Quality Assurance to ensure compliance with any applicable regulations and legislation (including but not limited to Nagoya Protocol and HTA etc).
- Manage the Culture Collections Quality Team at UKHSA Porton, including undertaking staff appraisals and the setting of objectives consistent with the quality assurance strategy.
- Management of the batch release process to ensure that the accuracy and quality of the products is assured.
- Provide advice and guidance to the Head of Culture Collections and Operational leads in all aspects of quality assurance and regulatory requirements.
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
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 description
Job responsibilities
Selection process details
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.
If you are successful at this stage, you will progress to an interview.
Please ensure that your statement of suitability contains no personal identifiers e.g. name in either the file name or content of the document.
STAGE 2 INTERVIEW
This competition will involve an interview by video or Face-to-face.
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 in relation to the criteria set out in the Person Specification.
Please note, as part of the interview process, you may be asked to prepare to deliver a presentation or complete a test.
Expected Timeline:
Advert close: 23:55hrs on 31st July 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.
Shortlist: w/c 7th May 2023
Interviews: TBC
Please note these dates could be subject to change.
Job description
Job responsibilities
Selection process details
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.
If you are successful at this stage, you will progress to an interview.
Please ensure that your statement of suitability contains no personal identifiers e.g. name in either the file name or content of the document.
STAGE 2 INTERVIEW
This competition will involve an interview by video or Face-to-face.
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 in relation to the criteria set out in the Person Specification.
Please note, as part of the interview process, you may be asked to prepare to deliver a presentation or complete a test.
Expected Timeline:
Advert close: 23:55hrs on 31st July 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.
Shortlist: w/c 7th May 2023
Interviews: TBC
Please note these dates could be subject to change.
Person Specification
Education & Qualification
Essential
- oScience degree or equivalent in a related discipline.
- oPostgraduate qualification or demonstrable equivalent experience.
- oPrevious laboratory experience.
- oExperience in applying a range of standards, regulations. and guidelines applicable to regulated laboratories.
- oUnderstanding of quality assurance principles and procedures.
- oExperience of implementation of quality systems/accreditation standards.
- oFamiliar with electronic quality management software solutions.
Desirable
- oQuality management qualification (CQP MCQI or ISO 9001:2015 lead auditor)
- oEvidence of continuing professional development
- oExperience in managing quality in a regulated or accredited laboratory (ISO 9001, ISO17025 or ISO 15189)
- oExperience managing an electronic quality management software system.
Person Specification
Education & Qualification
Essential
- oScience degree or equivalent in a related discipline.
- oPostgraduate qualification or demonstrable equivalent experience.
- oPrevious laboratory experience.
- oExperience in applying a range of standards, regulations. and guidelines applicable to regulated laboratories.
- oUnderstanding of quality assurance principles and procedures.
- oExperience of implementation of quality systems/accreditation standards.
- oFamiliar with electronic quality management software solutions.
Desirable
- oQuality management qualification (CQP MCQI or ISO 9001:2015 lead auditor)
- oEvidence of continuing professional development
- oExperience in managing quality in a regulated or accredited laboratory (ISO 9001, ISO17025 or ISO 15189)
- oExperience managing an electronic quality management software system.
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.
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).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
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.
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).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
