Quality Assurance Manager

Contents

• Location
• About the job
• Benefits
• Things you need to know
• Apply and further information

Porton Down, Salisbury (with regular travel to Colindale, London NW9 5EQ)

About the job

Job summary

Culture Collections is a large world leading biological resource centre which provides authenticated reference materials to scientists globally. The department contains five operational teams which supply Cell lines (ECACC), Clinical specimens (COVID Biobank), bacterial strains (NCTC), viral strains (NCPV) and fungal strains (NCPF) to scientific partners to support Public Health.

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. 

Job description

The Culture Collections Quality Assurance & Regulatory Manager within the Culture Collections team will report directly to the Head of Culture Collections. The post holder will 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.

Leading the management and application of the Culture Collections quality systems that assure product quality and batch release of product into saleable stock, and ensuring 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, and this is a responsibility of the post holder.

Previous experience in managing quality in a regulated or accredited laboratory (ISO 9001, ISO17025 or ISO 15189) is desirable, but not essential. However, the successful candidate must demonstrate an understanding of, and experience of, working in a regulated or accredited laboratory environment.

Main duties and Responsibilities 

• 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 and Colindale, 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
• Carry out the duties of a Person Designate for the Human Tissue Act license.

Person specification

Essential Criteria

You will be assessed on the below 7 essential criteria, which have been selected from the Job Description 

• Science degree or equivalent in a related discipline
• Postgraduate qualification or demonstrable equivalent experience
• Experience in applying a range of standards, regulations, and guidelines applicable to regulated laboratories
• Familiar with electronic quality management software solutions
• Understanding of quality assurance principles and procedures
• Experience of implementation of quality systems/accreditation standards
• Understanding of the principles of governance

Benefits

Alongside your salary of £51,824, UK Health Security Agency contributes £13,992 towards you being a member of the Civil Service Defined Benefit Pension scheme. Find out what benefits a Civil Service Pension provides.

• 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%

Contact point for applicants

Job contact :

• Name : Natasha Kukadia
• Email : [email protected]

Recruitment team

• Email : [email protected]

Further information

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: [email protected] 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 Home – Civil Service Commission (independent.gov.uk)

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