Job summary
An opportunity has arisen for a Quality Manager to support our laboratory facilities management team (FM).
As part of Sonic Healthcare UKs 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 UKs 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 UKs Quality Management Group apply and adhere 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 we have a corporate gym membership scheme with Better Gyms
Cash healthcare plan 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 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
Flexible working hours 40 hours standard working week
Job description
Job responsibilities
Facilities Management scope of operation is far reaching and has multiple touch points on the Groups
Laboratories, where, if failure occurs, can lead to accreditation non-compliance, and ultimately can
impact 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 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 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 of 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, ISO9001)
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 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
Job description
Job responsibilities
Facilities Management scope of operation is far reaching and has multiple touch points on the Groups
Laboratories, where, if failure occurs, can lead to accreditation non-compliance, and ultimately can
impact 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 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 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 of 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, ISO9001)
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 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
Essential
- Qualification in Quality Management or equivalent experience of working as part of or leading a quality management team.
- Post graduate degree in life sciences or equivalent
Experience
Essential
- Significant experience of working in quality management in a service
- facilities environment
- 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.
- Excellent Report writing experience.
Skills and Abilities
Essential
- 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 use of Microsoft Office.
- Able to write reports concisely and precisely.
- Excellent attention to detail skills.
- Excellent organisational & record keeping skills
Person Specification
Qualifications
Essential
- Qualification in Quality Management or equivalent experience of working as part of or leading a quality management team.
- Post graduate degree in life sciences or equivalent
Experience
Essential
- Significant experience of working in quality management in a service
- facilities environment
- 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.
- Excellent Report writing experience.
Skills and Abilities
Essential
- 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 use of Microsoft Office.
- Able to write reports concisely and precisely.
- Excellent attention to detail skills.
- Excellent organisational & record keeping skills
Additional information
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
