Job summary
This post sits in the High Containment Microbiology (HCM) department within the High Containment and Biological Services Division. HCM comprises highly specialised facilities and staff across the UKHSA Porton and Colindale sites to support the UK and international requirements for work at the highest levels of biocontainment. Department activities are driven by clinical and public health priorities, ensuring efficient and effective co-ordination of the UK response to disease outbreaks caused by high consequence pathogens in addition to carrying out defined research programmes. Both facilities undertake work at the highest categorisation of human and animal pathogens, Advisory Committee on Dangerous Pathogens (ACDP) and Specified Animal Pathogens Order (SAPO) Hazard Group 4.
Main duties of the job
The Regulatory Compliance Manager will support the UKHSA High Containment Microbiology department in achieving and maintaining compliance to regulations governing in vitro diagnostic medical devices (IVD). The postholder will lead a range of activities to support the compliance of the departments diagnostic assays for ACDP3 and ACDP4 viruses (including molecular assays, serology and virus culture) to UKHSA, IVD Regulations (IVDR) and ISO standards, including leading laboratory work to support assay development and validation, in conjunction with the Regulatory Compliance Officer, laboratory teams and the divisional Quality Team.
Location
Colindale, London
Address:
61 Colindale Ave, London, NW9 5EQ
*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
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
Job description
Job responsibilities
The job holder will be required to carry out the following responsibilities, activities and duties:
- To ensure that High Containment Microbiology complies with IVD regulations, relevant ISO and other accreditation standards in collaboration with the IVD/DDEU Programme Core Team, divisional and UKHSA Quality teams, and other senior staff.
- To support for the continuous improvement in service delivery and quality compliance within all areas of High Containment Microbiology, using modern methods in ensuring the highest standards of quality, regulatory and process control.
- To provide advice to High Containment Microbiology on all aspects of Regulatory and Compliance and contribute to preparation of proposals that contribute to innovations that enhance the effectiveness of High Containment Microbiology
- To obtain and maintain CL3 and CL4 competence to support department clinical and research projects
(Please see the attached job description for a full list of duties)
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.
Job description
Job responsibilities
The job holder will be required to carry out the following responsibilities, activities and duties:
- To ensure that High Containment Microbiology complies with IVD regulations, relevant ISO and other accreditation standards in collaboration with the IVD/DDEU Programme Core Team, divisional and UKHSA Quality teams, and other senior staff.
- To support for the continuous improvement in service delivery and quality compliance within all areas of High Containment Microbiology, using modern methods in ensuring the highest standards of quality, regulatory and process control.
- To provide advice to High Containment Microbiology on all aspects of Regulatory and Compliance and contribute to preparation of proposals that contribute to innovations that enhance the effectiveness of High Containment Microbiology
- To obtain and maintain CL3 and CL4 competence to support department clinical and research projects
(Please see the attached job description for a full list of duties)
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.
Person Specification
Essential/Desirable Criteria
Essential
- Science degree or equivalent experience in microbiology or a related pathology discipline
- Postgraduate scientific qualification or demonstrable equivalent experiential learning gained in a medical laboratory environment
- Evidence of continuing professional development and willingness to continue the learning process through academic or practical experience
- Substantial laboratory experience working in an accredited medical laboratory
- Experience in applying a range of standards, regulations and guidelines applicable to clinical laboratories
- Understanding of IVD governance principles and procedures
- Understanding and experience of change management
- Experience of managing projects
- Sound knowledge of common IT programmes, including Q Pulse and excellent keyboard and IT skills.
- Excellent verbal and written communication, data analysis and statistical skills
- Experience of attending management meetings and presenting information to management
- Ability to work on own initiative and as part of a team
- Excellent interpersonal, negotiating, and organisational skills, self-motivated, analytical and adaptable
- Willingness to obtain and maintain competence in Containment Level 3 & 4 laboratories, and to obtain and maintain SC level security vetting
- An understanding of and commitment to equality of opportunity and good working relationships.
Desirable
- Quality management qualification and knowledge of Regulatory compliance
- An understanding of microbiology and its application in clinical practice and public health
Person Specification
Essential/Desirable Criteria
Essential
- Science degree or equivalent experience in microbiology or a related pathology discipline
- Postgraduate scientific qualification or demonstrable equivalent experiential learning gained in a medical laboratory environment
- Evidence of continuing professional development and willingness to continue the learning process through academic or practical experience
- Substantial laboratory experience working in an accredited medical laboratory
- Experience in applying a range of standards, regulations and guidelines applicable to clinical laboratories
- Understanding of IVD governance principles and procedures
- Understanding and experience of change management
- Experience of managing projects
- Sound knowledge of common IT programmes, including Q Pulse and excellent keyboard and IT skills.
- Excellent verbal and written communication, data analysis and statistical skills
- Experience of attending management meetings and presenting information to management
- Ability to work on own initiative and as part of a team
- Excellent interpersonal, negotiating, and organisational skills, self-motivated, analytical and adaptable
- Willingness to obtain and maintain competence in Containment Level 3 & 4 laboratories, and to obtain and maintain SC level security vetting
- An understanding of and commitment to equality of opportunity and good working relationships.
Desirable
- Quality management qualification and knowledge of Regulatory compliance
- An understanding of microbiology and its application in clinical practice and public health
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).
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).
