Quality Manager

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

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

Minimum requirements:

• Experience of operating management systems within pathology laboratories to ISO 15189 standards.
• Minimum 3 years’ experience in either ISO 15189, ISO 9001 or ISO 17025 accredited environments. 
• Qualification in quality management
• Auditing experience
• Experience and understanding of root cause analysis

Desirable:

• HCPC registered Biomedical Scientist status
• 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

Additional Information

Salary £45,000 to £50,000 depending on experience.

• 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