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Business Systems Manager
- Leading UK Healthcare Data business
- Proficiency with ISO9001 and Clinical Safety
About Our Client
The business represents the combination of a number of highly successful and well recognised solutions with market leading positions in the provision of electronic based point-of-care decision support knowledge bases, as well as actionable orders, rules and guidance.
Delivering excellent quality solutions to its customers is a core principle. The Business Systems Manager is responsible for designing, maintaining and improving the system that ensures the quality of these solutions.
The ISO 9001 accreditation is globally recognised and is a precursor to doing business in certain markets. My client has won contracts that it would not have been able to without ISO certification.
As part of its drive to improve patient safety, my client has implemented a Clinical Risk programme, designed to meet the requirements of the appropriate NHS standards. The primary purpose is to identify and quantify risks at the start of a new product life cycle. This will enable new products to include solutions to mitigate and minimise risks at the design stage, thereby reducing the costs associated with errors and corrective actions.
Purpose of the role:
- Promoting quality achievement and performance improvement
- Developing and implementing quality management strategy and plans, to support in the achievement of the annual business plan and longer term strategy.
- Developing and maintaining systems to facilitate:
- Retention of Accreditation to ISO 9001:2008.
- Compliance with relevant national and international standards
- Continual improvement of work flows to ensure they are streamlined, effective and consistent
- Facilitating measurement of performance against established standards and KPI's
- Defining processes and procedures in conjunction with other key stakeholders
- Ensuring that any changes in standards created by external bodies are communicated and incorporated within internal quality management system
- Establishing and implementing necessary communications and training for the continuous improvement and awareness of quality and system improvement issues across all departments
- Managing the programme of internal audit
- Liaising and co-operating with quality management and standards bodies (eg BSI)
- Clinical Risk Management compliant to NHS Standard ISB 0129.
- Compliance to the Medical Device Directive (MDD) 93/42/EEC & Amending Directive 2007/47/EC (MDD).
- Maintain NICE accreditation.
- Maintaining and implementing a robust Business Continuity Plan.
- Ensure all quality related procedures & systems are established and kept up-to-date.
- Act as prime contact with the external quality auditor; schedule and co-ordinate all internal quality audits.
- Monitor the Management System and report any significant non-conformance issues, ensure corrective action process is robust and improvements made where issues arise.
- Ensure the Clinical Risk Management system is fully documented and implemented in line with the requirements of the NHS.
- Pro-actively monitor processes for efficiency and mentor individuals involved as required.
- Define and refine processes and procedures in conjunction with key internal stakeholders.
- Supervise and manage the internal audit team and their activities
- Co-ordinate training of employees of aspects of the Management System as relate to their role, and effect changes and improve awareness of quality and system improvement issues across the Company.
- Communicate changes to any standards and ensure that these are understood and incorporated to the internal management system as needed.
- Assess new solutions against Medical Device classification and any other relevant accreditation's.
- Assess new solutions in conjunction with clinical and product expertise; review by Senior Management Team prior to formal classification.
- Maintain the technical file and associated documentation required by the MDD for inspection by external bodies. Incident reporting to MHRA as required by the MDD.
- Monitor and maintain NICE accreditation, informing NICE of any relevant major product changes.
- Document, maintain, implement and exercise an appropriate Business Continuity Plan.
- Ensure Health and Safety is in line with current legislation. Pro-actively manage health and safety activities.
The Successful Applicant
The successful individual will have significant experience in implementing business systems in a complex IT environment. The function requires a thorough individual who has an analytical mind. As much of the role will focus on reviewing the work of others. A person who has a significant track record in implementing business systems would be ideally suited to this position.
- At least 3 years work experience in a commercial environment, including exposure to ISO 9001: 2008.
- Experience in applying risk management methodology.
- Ability to produce business documentation for use by senior NHS personnel.
- Fully capable in use of all Microsoft Office products as well as experience of Microsoft Visio.
What's on Offer
This opportunity offers the successful candidate to operate from both the South West and London offices of the business. Day rate - Highly competitive + expenses (where necessary).