Laboratory Quality Officer

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 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 values making a difference in their day-to-day work. This is a unique opportunity to make a difference in the emerging Digital Pathology field.

About this Role

This role is advertised for a Laboratory Quality Officer, Oxford, who is an experienced scientific and technical professional with a good understanding of accredited histopathology laboratory operations in the context of clinical trials and digital clinical laboratory services. In addition to their scientific, technical, and administrative/managerial 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, adept at engaging diverse stakeholders, innovative with problem-solving, and possess a collaborative spirit within a team environment.

Responsibilities:

1. Quality lead to support digital scanning and histopathology laboratory operations in the UK.
2. 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, ensuring compliance.
3. Write new documents, procedures, and work instructions as required with the laboratory team.
4. Closely collaborate with project teams to expand and deliver new laboratory services.
5. Work closely with clinical trial sponsors and CROs to align processes with ICH GCP guidelines.
6. Lead and coordinate change management activities to document changes within the quality management system.
7. Oversee document control within the laboratory; ensure documents are reviewed in a timely manner; and that all documents issued are correctly controlled & managed in line with the document control procedure.
8. Oversee the audit calendar for the laboratory; ensuring all internal and supplier audits are carried out in a timely manner, in liaison with the Operations Manager.
9. Review all completed audits before they are submitted to the Quality Manager for acceptance, ensuring they have been completed to the required standard.
10. Monitor laboratory audit non-conformance, CAPAs, and error logs; liaise with the Operations Manager to ensure that actions are appropriately delegated and closed within the required timeframe.
11. Compile error log reports on a monthly basis & provide monthly trend analysis for KPI reviews.
12. Work closely with managers to provide advice and support to staff in the implementation of the quality management system, particularly regarding documentation, training, audit, and non-conformance management.
13. Act as the point of contact for the Quality Manager within the laboratory, ensuring that any relevant instructions and information from the Quality Manager are disseminated.
14. Ensure that all employees are aware of their responsibilities regarding quality management; are adequately trained; and that all staff performing quality tasks have completed relevant competencies for performing such tasks.
15. Act as the subject matter expert and point of contact for laboratory quality matters arising in the context of clinical trials, including supporting our customers with their regulatory audits for their clinical trials.
16. Manage participation in the EQA schemes that the laboratory subscribes to, on behalf of the Operations Managers.
17. Liaise regularly with the Operations Manager on quality management issues, identify areas of concern, and take action where necessary. Share learning and good practice with other services within the company.
18. Work with the Operations Manager in the provision and collation of evidence for UKAS. Assist the Quality Manager with closing non-conformities and implementing corrective actions.
19. Coordinate regulatory audits of laboratory services as required, for example UKAS, MHRA.
20. Support the development and implementation of AI-assisted pathology tools for clinical and preclinical use, ensuring regulatory acceptance as applicable.
21. Support any other duties as assigned by quality management.
22. Periodic international travel will be required to company sites, up to 10% travel will be required.
23. Training required for the role may include ISMS, GLP, DocuSign, and GDPR/HIPAA awareness.

Required Skills and Experience:

1. Bachelor’s degree in Biomedical Science or similar Life Science qualification.
2. At least 5 years of experience in ISO 15189 accredited histopathology laboratories.
3. Strong knowledge of GLP regulations and current guidelines such as 21 CFR 58, 21 CFR 11, OECD Principles of GLP and/or of GCP regulations and current guidelines such as 21 CFR 50, 21 CFR 54, 21 CFR 56, 21 CFR 312.
4. Experience with digital pathology and digital biomarkers.
5. Excellent communication, collaboration, and leadership skills.
6. Strong problem-solving and analytical skills.
7. Ability to work under pressure and meet tight deadlines.

Desirable Skills and Experience:

1. Experience with both GLP and GCP regulations will be ‘a distinct advantage’.
2. Knowledge of AI cloud computing, electronic data archiving is an advantage.
3. Experience with Gen AI tools is an advantage.

Soft Skills:

1. 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.
2. You bring a sense of urgency to the work that you do and are able to execute tasks by using your initiative.
3. You enjoy innovating and bringing new ideas to the table.
4. You like to have autonomy in your role and the independence to manage your own time and workload.
5. You are highly collaborative and enjoy working with lots of different teams and people.
6. You thrive in a fast-paced environment and can manage changing priorities.
7. You have great written and oral English language skills.

What are the benefits of working with Diagnexia?

1. Competitive salary with performance-based annual increments.
2. Healthcare benefits.
3. Competitive annual leave.
4. A true sense of meaning in your work by contributing to better patient outcomes.
5. The opportunity to work alongside a world-class high-performing team in a hyper-growth startup environment.
6. A chance to work on exciting, challenging, and unique projects.
7. Regular performance feedback and significant career growth opportunities.
8. A highly collaborative and supportive multicultural 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, 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.

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