We are looking for Quality Assurance Manager who will be responsible for supporting the establishment of Our Future Health’s integrated management system, working with stakeholders across the organisation to ensure compliance with internal and external requirements, and driving continuous improvement. You will also support key certification activities to support Our Future Health’s organisational aims and objectives.
Our Future Health will be the UK’s largest ever health research programme, bringing people together to develop new ways to detect, prevent and treat diseases. We are a charity, supported by the UK Government, in partnership with charities and industry. We work closely with the NHS and with public authorities across all nations and regions of the UK.
What you’ll be doing
This role will play a key part in the creation, maintenance, and improvement of an integrated management system that can be applied across the organisation, initially for quality and information security.
Your key responsibilities will include but not be limited to:
* Supporting the Head of Quality & Management Systems in the creation, maintenance, and improvement of an integrated management system that can be applied across the organisation; initially for quality and information security, but that may also be applied later/as necessary to business continuity, data protection, environmental and H&S.
* Driving key management system activities to ensure organisational compliance with applicable international standards such as ISO 27001 and ISO 9001, regulatory requirements, and with assurance schemes such as Cyber Essentials Plus and the NHS Data Security and Protection Toolkit.
* Supporting the Procurement Team to ensure the quality of suppliers, through appropriate due diligence and evaluation.
* Working with stakeholders across the organisation to ensure requirements are understood and implemented. This would include close collaboration with other compliance colleagues across the organisation such as those in Security, Ethics, Data Protection, and Programme Operations.
* Working alongside our Regulatory colleagues to ensure that regulatory requirements for our products and services are complied with within the management system.
* Developing, maintaining, and improving organisational policies, processes, and procedures.
* Conducting internal and external audits to verify compliance with requirements, and to highlight opportunities for improvement.
* Conducting activities associated with external certification assessments e.g., ISO 27001, ISO 9001, CE+, NHS DSP Toolkit, etc.
* Collating information to report on management system performance to the Executive Board of Our Future Health.
* Continuously seeking and driving opportunities for improvement across the organisation.
You will have experience working within organisations that hold large volumes of extremely sensitive data and will be used to working alongside regulatory teams to ensure mandatory requirements are implemented into management systems.
To succeed, you will also have some of the following skills and experience:
* Creating, implementing, maintaining, and improving management systems.
* Management system certification activities; including liaising with external certifying bodies.
* Working with a wide range of stakeholders across organisations to drive compliance effectively communicate requirements/good practice.
* Creating and implementing policies and processes.
* Conducting internal and external audits.
* Driving root cause analysis and corrective and preventive actions.
* Knowledge of Management Systems and incorporating compliance requirements e.g. Regulatory, into management systems.
* Ability to effectively communicate in a non-technical, friendly manner while fostering a positive culture towards quality and compliance.
* Qualified as a QMS/ISMS Lead Auditor.
* Knowledge of ISO 9001 and/or ISO 13485.
* Medical device regulations experience is advantageous.
* Working within a Health tech/health research environment is advantageous.
Knowledge of the following would also be desirable:
* ISO 15189
* ISO 17025
* ISO 27001
* Cyber Essentials
* NHS Data Security & Protection (DSP) Toolkit
* £54,000 - £59,000 basic salary per annum.
* Generous company pension package with employer contributions of up to 12%.
* 30 days annual leave (plus bank holidays).
* Continuous career development with regular appraisals and learning and development opportunities.
* A lovely new office in Holborn, Central London – we offer flexible and remote working arrangements.
Join us - let’s prevent disease together.
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