National Quality and Regulatory Manager (QM)

Medical Community Reading, London

National Quality and Regulatory

Manager (QM) 

 

 

About TMC

Telemedicine Clinic (TMC), a Unilabs company, pioneered teleradiology services in Europe when it was founded in 2002. TMC has become a vital partner for more than 120 radiology departments in the UK, Sweden, Denmark, and Norway.

This year our team of more than 320 highly specialised radiologists will report over 800,000 cases, making a significant positive impact on patients’ lives and hospital staff. In addition to our radiology reporting service, TMC offers IT-infrastructure and software to its client hospitals, as well as training for radiologists (Unilabs/TMC Academy).  

Besides this excellent track record, we like to think that what’s most special about TMC is its culture. Many people say that TMC has the feel of a thriving start-up, and they are surprised at how kind and caring we are when dealing with each other and our business partners.

Additionally, TMC’s core purpose aligns with Unilabs’ mission of making quality healthcare accessible to all, regardless of location. A quality-driven culture involves effective communication and strong relationships with the supply chain.

If you are interested, you can learn more about our culture in our TMC Culture Book.

 

Mission Role, Department and Organisational Context

As a Quality and Regulatory Manager, you´ll lead the Quality Management department within TMC, including Clinical Governance and the Incident Management workflow.
 
We are looking for someone passionate about quality and driven by continuous improvement. You love to provide excellent patient care and have a background in healthcare. You are a radiographer, nurse, or other clinical professional with Radiology experience who can support our medical complaints’ investigations. You like to work in an international environment and be part of a smaller team within a bigger organisation.

TMC believes in Quality, not only within the medical field but in everything we do. One way to ensure we focus on providing high quality in all fields is to comply with recognised quality standards (ISO 9001, ISO 27001, ISO 27701, QSI, and CQC), which helps the company to focus on the right things.

Quality is not new to TMC. We achieved ISO 9001 certification in 2006, ISO 27001 in 2013, and QSI in 2016 and have successfully maintained these. This means we have established processes in place – you will not need to start from scratch, although we are constantly improving and changing our processes to become better and meet the Unilabs Group requirements and standards.

The Quality department ensures that the Quality Management System and TMC quality standards are implemented, maintained, and controlled. Clinical Governance is significant to us, and we carry out several internal and external audits to ensure that our work is top quality.

We always work to ensure that everything we do is compliant with local and national regulations, standards, and guidance. Tracking and management of incidents help us to learn from errors and identify ways of continuous improvement, which is essential in our environment.

General activities done by the team:

          Implementation and maintenance of quality and security standards

          Training of Quality standards and Compliance

          Control and monitoring of incidents, non-conformities

          Maintenance of the Management system

          Documentation management

          Risk management

          Clinical Governance

 

The position is based in the UK, although it covers all TMC’s entities. Occasional traveling is required, both, to visit UK clients and other offices of TMC.

We offer a hybrid model where we expect the manager to be regularly at the Reading office.  It will require working with all the TMC departments and entities, as well as with other Quality Managers in the group of Unilabs.

The Quality and Regulatory Manager reports to the Head of Quality and Regulatory of TMC. In her absence, the manager reports to the Unilabs Group Quality Director. 

Role and Responsibilities

Core functions

  • Ensures that the quality management system is maintained and that we comply with applicable certifications, regulations, and standards from customers in all facilities of TMC.
  • Secures that TMC meets the healthcare standards managed by bodies such as CQC in the UK and the National Board of Health and Welfare in Sweden (Socialstyrelsen). 
  • Implements and ensures compliance with group policies and procedures.
  • Promotes a culture of quality by educating others in quality management system fundamentals, programs, and tools.
  • Develops quality goals and objectives in collaboration with Group and local functional heads, assist in executing these goals, and report results and any need for improvement to hierarchical superiors.
  • Prepares quality meeting data/presentations.
  • Conducts Quality Management Review meetings at least once a year in cooperation with our Business Unit teams and the Country Leadership Team.
  • Ensures non-conformances, adverse events, and complaints are identified and documented and timeliness requirements are met. Triages the incoming adverse events, assesses risk, assists in root cause analysis, and corrective action efforts. Monitors trends and creates reports for periodic quality meetings and management reviews.
  • Investigation of medical incidents to support our medical team (administrative tasks, preparing and selecting relevant information to share with the medical investigator)
  • Communication with our clients about complaints, adverse events, and incidents.
  • Plans and takes part in internal audits. Follow-up of actions following audits.
  • Supports the preparation of accreditation dossiers, accompanies auditors (e.g. ISO quality inspectors) during audits of the offices, and coordinates responses to audit findings.
  • Manages, reviews, and approves standard operating procedures, risk assessments, and change controls before the release of new systems (including AI) and changes in processes.
  • Ensures TMC complies with applicable legislation related to the systems (e.g. AI Act)
  • Communicates with local and accreditation/certification bodies, maintains and updates scope of accreditation, negotiates quotations with auditors and accreditation/certification bodies.
  • Establishes appropriate implementation of the risk management procedure in all offices and departments of TMC. Performs other duties as assigned.

 

Leadership

  • Sets the overall direction for the standardisation and harmonisation of quality-related processes considering the Unilabs group quality strategy and the big picture of internal and external aspects.
  • Identifies and drives changes in a future-oriented, solution-oriented, and proactive manner.
  • Creates an open-minded atmosphere that allows innovative thinking by encouraging others to express their point of view and listens carefully to extract business potential.
  • Manages a small team located in different countries.
  • Creates and nurtures good relationships with relevant stakeholders, both on TMC group level as on Unilabs Group level.

 

Required Education, Experience, Knowledge, Skills

Experience  Previous experience in Quality, either as Quality Manager, Quality Assistant, or responsible for Clinical Governance. Leadership experience. Experience in managing clinical complaints (adverse events, claims…). Previous experience and knowledge of quality improvement methodologies. It is a plus if you have experience with QSI and/or ISO 9001 and CQC standards preferable.

Educational background  Registered Radiographer or registered clinical professional within Radiology, or registered nurse.

MS Office Good level of Office 365.

 

Required Role-Based Competences

Organisation - You are used to plan organise workload and you have project management skills. Working autonomously and being on top of tasks is easy for you.

Communication skills – You have a clear thought process and the ability to find appropriate vocabulary and a suitable style, verbal and written. You feel comfortable to communicate to a wider audience and senior managers.

People Person You are kind and polite when dealing with others. You can convince and persuade others to do or follow up on things. You help to train new starters.

Ability to manage change  You are flexible, open to change, and promote change to others. You can guide people through change, and you find solutions and new ways of working.

Process Orientated You can work efficiently and think “lean”, you design process maps and help others to do the same.

Attention to detail  You are thorough when auditing, producing documentation and carrying out investigations. You pay attention to detail with your work and others.

 

What you can expect from us

TMC is a challenging and fun workplace with a diverse, international team (over 40 nationalities). Our business language is English.

Apart from making a living, people at TMC come to work every day because they want to make a difference in people’s health care. Everything we do is focused on diagnosing patients’ health problems quickly and correctly. This is what drives us.

 

How to Apply

If you find this opportunity attractive and challenging, we would love to hear from you. Please apply directly on the career website or contact Evelyn Kloetzer, Recruitment Manager at [email protected] or +34 93 55 00 750.