Right to Work
- Candidates must be based in the UK and have the right to work in the UK.
- We do not offer UK visa sponsorship for this UK‑based role.
About this Role
This role is advertised for a Laboratory Quality Specialist in Oxford. The specialist should have a good understanding of accredited histopathology laboratory operations in the context of clinical trials and digital clinical laboratory and reporting services.
The role is centered on proactively improving quality processes by preventing errors, defects and operational inefficiencies within laboratory workflows. It involves establishing and monitoring quality metrics across laboratory processes, analysing quality data, and leading root‑cause investigations and continuous improvement initiatives to enhance overall laboratory performance. Additionally, the specialist will implement, oversee and promote the laboratory quality management system.
You will be successful in this role if you are proactive, adept at engaging diverse stakeholders, innovative in problem‑solving, and collaborative within a team environment.
Responsibilities
- Support digital scanning and histopathology laboratory operations in the UK.
- Lead and coordinate data‑driven quality improvement initiatives by overseeing data monitoring, conducting root‑cause analysis and developing improvement plans, while driving effective change management within the quality management system.
- Evaluate and streamline end‑to‑end processes and procedures from customer onboarding to post‑delivery of services. Support automation and reduction of manual processes using technology.
- Oversee document control within the laboratory to ensure documents are reviewed, streamlined and correctly managed in line with the document control procedure.
- Develop and implement laboratory policies and procedures to ISO 15189:2022, GLP and IHC GCP requirements, ensuring quality and integrity of laboratory data. Maintain UKAS accreditation for laboratory operations and services to ISO 15189:2022.
- Oversee the audit calendar for the laboratory; ensure all internal and supplier audits are carried out timely, in liaison with the Operations Manager.
- Conduct and monitor laboratory audit non‑conformance, CAPAs and error logs; liaise with the Operations Manager to ensure actions are appropriately delegated and closed within the required timeframe.
- Compile error log reports monthly and provide monthly trend analysis for KPI reviews.
- Work closely with managers to advise and support staff in the implementation of the quality management system, particularly regarding documentation, training, audit and non‑conformance management.
- Act as the point of contact for the Quality Manager within the laboratory and ensure relevant instructions and information are disseminated.
- Ensure all employees are aware of their responsibilities with regards to quality management, are adequately trained, and have completed relevant competencies for quality tasks.
- Manage participation in the EQA schemes that the laboratory subscribes to, on behalf of the Operations Managers.
- Liaise regularly with the Operations Manager on quality management issues, identify areas of concern and take action where necessary, sharing learning and best practice with other services within the company.
- Work with the Operations Manager in the provision and collation of evidence for UKAS, assisting the Quality Manager with closing non‑conformities and implementing corrective actions.
- Coordinate regulatory audits of laboratory services as required (e.g., UKAS, MHRA).
- Support the development and implementation of AI‑assisted pathology tools for clinical and preclinical use, ensuring regulatory acceptance as applicable.
- Support any other duties as assigned by quality management.
- Periodic international travel to company sites may be required, up to 10% travel.
- Training required for the role may include ISMS, GLP, DocuSign and GDPR/HIPAA awareness.
Required Skills and Experience
- Bachelor's degree in Biomedical Science or a similar Life Science qualification.
- At least 5 years of experience in ISO 15189 accredited histopathology laboratories.
- Experience with digital pathology.
- Excellent communication, collaboration and leadership skills.
- Strong problem‑solving and analytical skills.
- Ability to work under pressure and meet tight deadlines.
- Experience and certification with process improvement methodologies is a distinct advantage.
- Experience with Generative AI tools and technology is a distinct advantage.
- Knowledge of AI cloud computing and electronic data archiving is an advantage.
- Demonstrated leadership skills and a willingness to develop further by owning the role from end to end.
- Sense of urgency to execute tasks using initiative.
- Enjoyment of innovation and new ideas.
- Autonomy in managing personal time and workload.
- High collaboration, working with various teams and people.
- Thriving in a fast‑paced environment with changing priorities.
- Great written and oral English language skills.
Benefits
- Competitive annual leave.
- A sense of meaning by contributing to better patient outcomes.
- Opportunity to work alongside a world‑class high‑performing team in a hyper‑growth startup environment.
- A chance to work on exciting and challenging projects.
- Regular performance feedback and significant career growth opportunities.
- A highly collaborative and supportive multi‑cultural team.
Deciphex is an equal opportunities employer and we are committed to the principle of equality. All qualified applicants will be considered for employment without regard to age, race, religious beliefs, political views, gender identity, sexual orientation, national origin, family or marital status (including pregnancy), disability, membership of the travelling community or any other classification protected by applicable law.
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