An opportunity has arisen for a Quality Manager to support our laboratory facilities management team (FM).
As part of Sonic Healthcare UK’s quality systems team, this individual will be a key point of contact between FM services, laboratories, and corporate departments.
Main duties of the job
This role will require a person who has an excellent understanding of and experience in a service facilities management environment, including stock procurement, supplier and asset management with a deep understanding of quality assurance and regulation.
The role will involve using the electronic QMS and ensuring that Sonic Healthcare UK’s quality framework is monitored; therefore, experience with data management, quality metrics, deviation management, and audit is required.
We are looking for an individual who can work independently, multitask, and can interact effectively with multiple functions across the organisation. Key to this is a requirement for excellent communication skills, both written and verbal.
Sonic Healthcare UK’s Quality Management Group applies and adheres to our organisational core values:
* We commit to service excellence.
* We treat each other with respect and honesty.
* We demonstrate responsibility and accountability.
* We are enthusiastic about continuous improvement.
* We maintain confidentiality.
The successful candidate should embody and demonstrate these values to foster and support our quality culture.
The role is based between our central London office and Elstree facility. Hybrid working may be supported.
About us
At TDL, we offer a variety of excellent staff benefits including:
Training and development opportunities supporting professional development.
Annual performance-related salary review.
As we are a private company, we are not restricted by salary bandings and so are able to negotiate appropriate salaries based on experience. This also means that annual salary reviews do not hit a band ceiling.
Discounted gym membership through a corporate gym membership scheme with Better Gyms.
Cash healthcare plan providing cash back on a variety of healthcare costs, including dentist and opticians.
Sick Pay Entitlement: 5 paid days in the first year of employment, 20 days thereafter.
Permanent Health Insurance and Death in Service Cover.
Life Assurance: providing salary continuation for long-term illness (six months qualifying period).
Employee Assistance Programme: supporting staff wellbeing.
Season Ticket Loan Scheme: interest-free loan for the cost of an annual travel ticket.
Perkbox: Access to additional staff perks and benefits such as high street discounts.
Company Pension Scheme: company and staff contributions which increase with service.
Competitive annual leave allowance: 23 days.
Job responsibilities
The Facilities Management scope of operation is far-reaching and has multiple touchpoints on the Group's Laboratories, where, if failure occurs, it can lead to accreditation non-compliance, and ultimately can impact the quality of service and patient safety. The purpose of this role is to administer and monitor the quality management system (QMS) within the Facilities Management (FM) directorate. To develop the QMS for the FM and Laboratory Support teams to create a culture of quality and getting it right the first time.
To oversee local Quality activities in accordance with good practice and appropriate accreditation or regulatory bodies e.g., ISO, MHRA, GXP, etc. The role would have QM remit over all Laboratory Services functions including procurement, goods in and out, kit making, asset management, supplier compliance, Engineering, and Sample Storage.
To include, but not be restricted to, the following duties:
1. To maintain and implement the Quality Policy for the department as directed.
2. To be responsible for retaining, maintaining, and continuously improving the QMS in the department.
3. To establish key quality indicators for overall analysis and trending and to identify opportunities for improvement to be actioned.
4. To have specific responsibility for quality oversight of the QPulse asset module, including auditing of asset management.
5. To support the supplier compliance officer with quality review and sign-offs of supplier approval.
6. To keep under review and update manufacturing safety notices.
7. To manage incident training for FM/LS staff, incident investigation, corrective and preventative actions plan, lessons learned, and driving improvement.
8. To organise and contribute to QMG meetings including annual management review.
9. To assist with the identification and establishment of quality objectives and Quality Indicators, including formulating a plan for achieving these against appropriate and relevant timescales.
10. To be responsible for the establishment and monitoring of a risk-based audit program to cover FM functions. This should include requirements of ISO15189 where appropriate and any other appropriate or relevant standards (e.g., ISO 13485, ISO 9001).
11. To support with change control training, embedding change culture, approving change action plans, risk assessment, and supporting communication on change.
12. To train and advise staff on verification and be the link person between FM and laboratories with respect to changing and/or verification of new products.
13. To ensure compliance and maintenance of the document control system for the department.
14. To ensure prompt response to enquiries and any follow-up, including incidents, investigations, and complaints. To ensure timely preparation of any summary and investigation reports, in accordance with the requirements of HSL QMG and compliance services.
15. To manage and where appropriate, deliver, the training programme for FM/LS staff in quality management systems.
16. To engage in activities associated with measuring and monitoring performance of the department including monitoring of key activities (Kelsius trending, cold storage, disposal of samples, saves records, etc.).
17. To support risk management, identification and mitigation of risks, and the departmental risk register.
18. To ensure all quality-related processes are performed in accordance with the relevant Health and Safety procedures.
19. As required, to provide support to other Group departments.
20. To monitor levels of compliance in areas of responsibility in order to identify actual and/or potential risk that may require escalation and take appropriate action.
Person Specification
Qualifications
* Qualification in Quality Management or equivalent experience of working as part of or leading a quality management team.
* Postgraduate degree in life sciences or equivalent.
Experience
* Significant experience of working in quality management in a service.
* Experience of working in laboratories or healthcare.
* Previous experience of leading on inspections for regulatory and quality assessment purposes.
* Significant experience required in incident identification, investigation, root cause analysis, and CAPA management.
* Auditing qualification or significant experience.
Skills and Abilities
* Excellent written and verbal communication skills.
* Excellent interpersonal skills.
* Ability to work on own initiative and as part of a team.
* Numerate.
* Highly skilled in the use of Microsoft Office.
* Able to write reports concisely and precisely.
* Excellent attention to detail skills.
Depending on experience, Up to £55,000 DOE inc. HCA.
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