Quality Manager

Source BioScience; North Runcton; On-site; GBP 40,000 - 55,000; Full time

Job summary

A diagnostics and genomic services company is seeking a Quality Manager to oversee the quality management system. This role includes ensuring compliance with ISO 15189 standards and managing audits. The successful candidate will have experience in pathology laboratories and will support quality objectives across multiple sites. This position is based in Chichester, with some potential flexibility to work in Nottingham.

Benefits

Life Assurance x4 salary

33 days holiday increasing with length of service

Option to buy and sell holidays

Cycle to work scheme

Qualifications

• Minimum 2 years’ experience in ISO 15189 accredited environments.
• Understanding of root cause analysis and auditing.
• Experience in risk management and GCP.

Responsibilities

• Manage the quality management system across sites.
• Perform audits of the management system at The Courtyard Laboratory.
• Support compliance with ISO standards and regulatory bodies.

Skills

Experience with ISO 15189 standards

Auditing experience

Root cause analysis

Education

HCPC registration as a Biomedical Scientist

Qualification in quality management

Tools

Q-Pulse software

Job description

Company Description

Source BioScience is an international genetic analysis, diagnostics and stability storage business serving the global research and healthcare markets. We pride ourselves on maintaining a friendly working culture that gives driven individuals the environment to succeed in an evolving and developing organisation.

Job Description

This is a full time role based on site in Chichester.

Closing date 31 August 2025.

Successful candidates will be required to provide references and are subject to a DBS Check prior to starting. Due to the volume of expected applications we reserve the right to close this advert prior to the closing date, we apologise that we are unable to respond individually to each application. If we have not contacted you within 7 working days your application has been unsuccessful and your details have not been retained. Please feel free to apply for any other position you may see in the future.

The role has responsibility for the day-to-day management of the quality management system within Source BioScience, as well as supporting wider operation of quality across all sites within the business and will be critical for driving continual improvement across the company via feedback from the management system.

The Source BioScience quality management system is in place across the Cellular Pathology/Healthcare (Source LDPath) and Genomics (Source Genomics) business units, and incorporates accreditation to ISO 15189 and ISO 9001, Good Clinical Practice (GCP), and registration with the CQC and HTA. The focus of the role will be cellular pathology and ISO 15189 accreditation but will support quality across all areas of the business.

This role will support the Head of Diagnostics Development & Quality in the ongoing delivery of quality management using Q-Pulse software, maintaining ISO 15189 and ISO 9001 accreditation, other relevant standards and ensuring regulatory compliance with CQC, MHRA, HTA and any other relevant regulators.

You will have a high level of responsibility to ensure the successful delivery of pathology and genomics services through effective management that meets the needs of users, in line with our company vision and quality objectives.

Source BioScience has locations in Nottingham, Cambridge and Chichester, providing diagnostic healthcare services (cellular pathology and molecular diagnostics) and genomics services to industry and academia. The position is based at the Orchard Place site in Nottingham, but following discussion could be based in Chichester should this be preferential for the candidate. The role will require infrequent visits to other sites in the business as and when required (e.g., performing audits).

Qualifications

Person Specification:

Minimum requirements:

• Experience of operating and being responsible for management systems within pathology laboratories to ISO 15189 standards.
• Minimum 2 years’ experience in either ISO 15189, ISO 9001 or ISO 17025 accredited environments.
• Auditing experience
• Experience and understanding of root cause analysis
• HCPC registered Biomedical Scientist status

Desirable:

• Qualification in quality management
• Experience of cellular pathology, molecular techniques, sequencing and genomics.
• Experience with GCP/clinical trials
• Familiarity with Q-Pulse
• Experience in risk management, ISO 27001 or DCB 0129/0160

Day to day management of the quality system at the Courtyard Laboratory and supporting implementation, consisting of:

• Performing audits of the management system, managing the audit schedule and making sure this is complete on time for The Courtyard Laboratory.
• Management of the Q-Pulse eQMS system:
• Workflow module (incident reporting/CAPA).
• Audit Module
• Document module
• Customer & Supplier modules
• Asset modules
• Administration
• Process improvement and incident & complaint management.
• Incident investigation and root cause analysis, including supporting other departments in the business to complete investigations appropriately, ensuring corrective and preventive actions are effective.
• Writing, and review of quality policies, SOPs and documents.
• Quality review and approval of documents across the business and ensuring appropriate document control is implemented.
• Ensuring the validation and verification policy is adhered to, ensuring there is a process in place for performing equipment, procedures, methods and software validations/verifications and maintaining in a validated state.
• Support the Clinical Risk Management process through integration into the management system and management of risk assessments and failure modes effects analysis.
• Contributing to the Annual Management Review (AMR) and preparing quality reports.
• Produce monthly quality reports, reporting on KPIs and quality objectives for The Courtyard Laboratory.
• Supporting the business in achieving quality objectives – ensuring these are set, monitored and actioned.
• Co-ordinating the internal awareness of the needs and requirements of the users through the AMR, assessment and audit feedback, complaints, incidents and KPI/quality objectives.
• Provide training for staff undertaking quality related activities, as required. (e.g., training in performing audits and root cause investigation).
• Liaise with, lead and support accreditation and certification assessment visits and responses at The Courtyard Laboratory.
• Support any third-party audits by regulators or clients.
• Supporting quality leads within departments and at other sites within the business, with occasional travel if necessary (such as performing audits).
• Provide training for quality leads and any other staff undertaking quality related activities, as required.
• Deliver the expectation of the service users whilst also balancing the interests of the company.
• To lead by example, demonstrating professionalism to colleagues commensurate with post.
• To comply with safe working practises in accordance with Company safety policies
• To participate in the Annual Joint Staff Review process, in accordance with Company Policy.
• To perform any other duties as may be reasonably required commensurate with grade and experience.
• Attend any training endeavours as appropriate to the role or as reasonably requested by Line Manager.

Additional Information

Income Protection

• Life Assurance x4 salary
• Employee Assistance Programme
• Medicash health cash plan
• Shopping & leisure discount portal
• Virtual GP Service
• mProve Yourself health and wellbeing resources
• SkinVision App
• Able Futures Mental Health support
• 33 days holiday (inclusive of bank holidays) increasing with LOS
• An extra day off on your birthday
• Option to buy and sell holidays
• Cycle to work scheme