Location: Full time onsite in our Exeter site.
Right to Work: Candidates must be based in the UK. We are unable to offer visa sponsorship for this role.
About this Role
This role is advertised for a Laboratory Quality Officer, Exeter, is a quality professional who has a good understanding of accredited histopathology laboratory operations both in the context of digital clinical histolopathology laboratory and reporting services. In addition to their scientific, technical and administrative role, they will have responsibility for implementing, overseeing and promoting the laboratory quality management system in their area.
You will be successful in this role if you are proactive in taking initiative, you are adept in engaging diverse stakeholders, you are innovative with problem-solving, and you have a collaborative spirit within a team environment.
Responsibilities:
- Quality support to digital scanning and histopathology laboratory operations in the UK.
- Collaborate closely with cross functional teams including customer support, pathologist management, IT, automation & integration engineers, CMO, business development, laboratory operations, QA, regulatory affairs etc to deliver highest quality clinical services to customers.
- Develop and implement laboratory policies and procedures to ISO 15189:2022, ensuring quality and integrity of laboratory data. Maintain UKAS accreditation for laboratory operations and services to ISO 15189:2022, ensuring compliance to these.
- Manage and oversee document control within the laboratory; to ensure documents are reviewed in a timely manner; and that all documents issued are correctly controlled & managed in line with the document control procedure in coordination with senior quality services manager..
- Lead and co-ordinate change management activities to document changes within the quality management system. Co-ordinate with R&D, software development, technology teams, Quality Assurance colleagues, Regulatory Affairs and other stakeholders when introducing new technologies, including AI systems, automations, integrations, into Clinical Services.
- Oversee the audit calendar for the laboratory; ensuring all internal audits are carried out in a timely manner, in liaison with the Operations Management.
- Monitor and manage laboratory audit non-conformance, complaints, CAPAs and error logs; liaise with the Operations Manager/senior quality services manager to ensure that actions are appropriately actioned and closed within the required timeframe.
- Liaise regularly with the Operations Manager on quality management issues, identify areas of concern and take action where necessary escalate to senior quality services manager as appropriate.. Share learning and good practice with the other services within the company.
- Lead quality and clinical risk management activities with various stakeholders including maintaining risk registers, process diagrams, risk reviews, coordinating risk mitigations activities.
- Manage and coordinate laboratory and equipment validation activities with various stakeholders.
- Oversee and support in complying with quality KPI on a monthly basis & provide monthly trend analysis for KPI reviews.
- Ensure that all employees are aware of their responsibilities with regards to quality management; are adequately trained; and that all staff performing quality tasks have completed relevant competencies for performing such tasks.
- Work closely with management in providing advice and support to staff in the implementation of the quality management system, particularly in regards to documentation, training, audit and non-conformance management.
- Manage participation in the EQA schemes that the laboratory subscribes to, on behalf of the Operations Managers.
- Support regulatory audits of laboratory services as required, for example UKAS.
- 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 service management.
- 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 similar Life Science qualification
- At least 3 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
- Work full time on site at the Exeter laboratory
- You will have shown leadership skills in previous positions and are keen to develop these skills further by owning your role from end to end.
- You bring a sense of urgency to the work that you do and are able to execute on tasks by using your initiative.
- You enjoy innovating and bringing new ideas to the table.
- You like to have autonomy in your role and the independence to manage your own time and workload.
- You are highly collaborative and enjoy working with lots of different teams and people.
- You thrive in a fast paced environment and can manage changing priorities.
Desirable Skills and Experience
- Knowledge of AI cloud computing, electronic data archiving is an advantage
- Experience with Gen AI tools is an advantage
What are the benefits of working with Diagnexia?
- Competitive salary with performance based annual increments.
- Healthcare benefits
- Competitive annual leave
- A true sense of meaning in your work by contributing to better patient outcomes.
- The opportunity to work alongside a world-class high performing team in a hyper-growth startup environment.
- A chance to work on exciting,challenging and unique projects.
- Regular performance feedback and significant career growth opportunities.
- A highly collaborative and supportive multi cultural team.
About the Company
Diagnexia, a subsidiary of Deciphex: Accelerating Certainty and Pioneering Pathology Services.
Diagnexia, a leading provider of pathology services, operates as a subsidiary of the parent company, Deciphex. Established in Dublin in 2017, Deciphex has rapidly expanded to become a global team of over 190 professionals, offering innovative software solutions to address the pathology gap in both research and clinical areas. With a mission to accelerate the drug development process and provide timely, accurate diagnoses for cancer patients, Deciphex has established a strong presence through its offices in Dublin, Exeter, Oxford and Chicago.
As part of the Deciphex family, Diagnexia leverages its expertise to provide cutting-edge diagnostic solutions to healthcare organizations worldwide. Our cloud-based platform enables hospitals to easily and rapidly send cases for a consultation to our team of expert subspecialists. We are dedicated to improving patient outcomes and helping healthcare organisations stay at the forefront of the industry.
We are software developers, clinical specialists, AI engineers, operations professionals and so much more, all working as one team to support our customers and patients. Our team culture is built on trust. We give our team the space they need to deliver results and the environment to ensure they can enjoy doing it.
We are looking for a highly motivated individual who is excited to take on challenges and value making a difference in their day-to-day work. This is a unique opportunity to make a difference in the emerging Digital Pathology field.
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, affectional or sexual orientation, national origin, family or marital status (including pregnancy), disability, membership of the travelling community or any other classification protected by applicable law.
