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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 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, is an experienced scientific and technical professional who has a good understanding of accredited histopathology laboratory operations both in the context of clinical trials and digital clinical laboratory and reporting 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 in engaging diverse stakeholders, innovative with problem-solving, and have a collaborative spirit within a team environment. Responsibilities: Quality lead to support digital scanning and histopathology laboratory operations in the UK. 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 to these. Write new documents, procedures, work instructions as required with the laboratory team. Closely collaborate with project teams to expand and deliver new laboratory services. Work closely with clinical trial sponsors and CROs to align processes with ICH GCP guidelines. Lead and co-ordinate change management activities to document changes within the quality management system. 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. 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. Review all completed audits before they are submitted to the Quality Manager for acceptance, to ensure they have been completed to the required standard. 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. Compile error log reports on a monthly basis & provide monthly trend analysis for KPI reviews. Work closely with managers 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. Act as the point of contact for the Quality Manager within the laboratory, and ensure that any relevant instructions and information from the Quality Manager are disseminated. 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. 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. 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. Share learning and good practice with the 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. Co-ordinate regulatory audits of laboratory services as required, for example 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 traveling will be required to company sites, up to 10% travel will be required. 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 5 years of experience in ISO 15189 accredited histopathology laboratories. 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. Experience with digital pathology and digital biomarkers. Excellent communication, collaboration, and leadership skills. Strong problem-solving and analytical skills. Ability to work under pressure and meet tight deadlines. Desirable Skills and Experience: Experience with both GLP and GCP regulations will be 'a distinct advantage'. Knowledge of AI cloud computing, electronic data archiving is an advantage. Experience with Gen AI tools is an advantage. Soft Skills: 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. You have great written and oral English language skills. 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. 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.

Job description: Find out if this opportunity is a good fit by reading all of the information that follows below. Director Quality - Sterility Assurance Do you pride yourself on your integrity? We do what's right for employees, patients and partners, and so can you. Oxford Biomedica's Quality Assurance (QA) team is responsible for the company's quality processes and systems, in compliance with GMP, GLP and GCP guidelines. The team are accountable for internal and external audits, quality compliance and control. The Quality Director of Sterility Assurance will be responsible for championing Sterility Assurance principles and serve as the Quality technical leader in the areas of aseptic processing (via isolators) and microbiology, depyrogenation, irradiation and sterilisation. This role will be accountable for assuring quality assurance oversight of Sterility Assurance, Aseptic Processing Program, Environmental Monitoring and Microbial Control Policies. The Primary responsibility is to maintain sterility assurance of aseptically manufactured sterile drug products and viral vector products. This position requires in-depth understanding of cGMP regulations and guidelines related to sterility assurance and proven applications in an aseptic/sterile production environment. Your responsibilities in this role would be: Responsible for defining company policy and developing company strategies with respect to aseptic processing, aseptic techniques, isolator best practices, controlled environments, aseptic training & cleanroom behaviours, cleaning, disinfection, sterilisation, sterility testing and related areas. Establish and maintain the company contamination control strategies and oversee aseptic programs. Generate and maintain the contamination control strategy documents. Overseeing sporicidal processes (inc. VHP & BI activities), decisions on occluded surfaces, aseptic and media fills / process simulations for aseptically filled products. Responsible for ensuring compliance to applicable Quality Regulations, standards, and other regional requirements. Providing input in the design of manufacturing and sterility testing processes, controlled environments, and packaging from a microbiological standpoint. Promoting the understanding of and compliance to Sterility Assurance related regulations. Leading and/or supporting major investigations related to sterility assurance events (i.e. Adverse EM trends, media fill positives, sterility positives etc.) Review & approve any major/critical deviation, change proposal or other quality records with Sterility Assurance impact. Ensuring that suitable aseptic programs (including training, oversight, and monitoring) are in place and effective and that all sterilization processes are appropriately managed. Maintain aseptic and sterility assurance practices in alignment with current and future regulatory requirements and expectations. Conduct risk assessments, as needed, to ensure ongoing compliance. Audit (or support audits) of site sterility processes and suppliers providing sterile materials or microbiological services (as required). Act as sterility assurance SME with external regulators, clients, company management in addition to acting as SME for new product introductions and applicable capital projects. Generate technical reports, as required, to support business needs Report status of, and promote, Sterility Assurance to Senior Leadership. To be successful in this role, you will have the following skills and experience: BS degree in Microbiology or related field (advanced degree preferred) Experience in biopharmaceutical industry (prefer experiences in both large and small company environments) Experience of working in an aseptic manufacturing production environment, isolators & cleanrooms. Isolator experience, including VHP & BIs, aseptic processing, aseptic techniques, occluded surfaces aseptic and media fills / process simulation for aseptically filled products Experience of working with Sterility test isolators Experience in supplier quality and management of sterile processing suppliers. Sterile supplier auditing experience, desired Experience of developing and influencing business strategy, desired Experience in Sterility Assurance validation and product validation using varying sterilization methods. Must have a high technical knowledge of Sterility Assurance & Cleanroom standards, with demonstrated experience of implementation responsibility Direct experience of QA oversight of sterility assurance programs, aseptic programs, and microbial monitoring of aseptic manufacturing areas (including isolators) Strong working knowledge of worldwide regulations related to aseptic practices and sterility assurance and the ability to interpret these requirements into execution compliance Solid understanding of the principles of sterile manufacturing and Quality Systems required for a sterile manufacturing facility Experience interacting with regulatory authorities during regulatory inspections. Ability to self-manage and work effectively with internal & external stakeholders and parties, including regulatory agencies, with minimal oversight Ability to identify, prioritize, and implement actions to continuously improve operations and systems and manage risks Must be a strong leader and cross functional team player with ability to work effectively in a fast-paced matrixed environment while managing multiple projects simultaneously Must possess excellent verbal, written communication skill and good interpersonal skills Do you want to feel inspired every day? We're future-focused and our business is growing rapidly. We succeed together through passion, commitment and team work, and so can you. Collaborate. Contribute. Change lives No agencies please. Profile description: To be successful in this role, you will have the following skills and experience: BS degree in Microbiology or related field (advanced degree preferred) Experience in biopharmaceutical industry (prefer experiences in both large and small company environments) Experience of working in an aseptic manufacturing production environment, isolators & cleanrooms. Isolator experience, including VHP & BIs, aseptic processing, aseptic techniques, occluded surfaces aseptic and media fills / process simulation for aseptically filled products Experience of working with Sterility test isolators Experience in supplier quality and management of sterile processing suppliers. Sterile supplier auditing experience, desired Experience of developing and influencing business strategy, desired Experience in Sterility Assurance validation and product validation using varying sterilization methods. Must have a high technical knowledge of Sterility Assurance & Cleanroom standards, with demonstrated experience of implementation responsibility Direct experience of QA oversight of sterility assurance programs, aseptic programs, and microbial monitoring of aseptic manufacturing areas (including isolators) Strong working knowledge of worldwide regulations related to aseptic practices and sterility assurance and the ability to interpret these requirements into execution compliance Solid understanding of the principles of sterile manufacturing and Quality Systems required for a sterile manufacturing facility Experience interacting with regulatory authorities during regulatory inspections. Ability to self-manage and work effectively with internal & external stakeholders and parties, including regulatory agencies, with minimal oversight Ability to identify, prioritize, and implement actions to continuously improve operations and systems and manage risks Must be a strong leader and cross functional team player with ability to work effectively in a fast-paced matrixed environment while managing multiple projects simultaneously Must possess excellent verbal, written communication skill and good interpersonal skills Do you want to feel inspired every day? We're future-focused and our business is growing rapidly. We succeed together through passion, commitment and team work, and so can you. Collaborate. Contribute. Change lives No agencies please. We offer: We are a pioneering gene therapy business, and our mission is delivering life changing gene therapies to patients. We work together, motivated to make a difference, and so can you. We are pioneers; no one else does what we do. Gene therapy is the treatment of disease by the delivery of therapeutic DNA into a patient's cells. It is transforming medicine as we know it, long term and potentially curative treatments for a wide range of diseases are now possible. We are at the forefront of this exciting area. We have a strong reputation in gene therapy, with world leading expertise in lentiviral vectors. We have a leading, integrated platform of exclusive technologies to design, develop and bioprocess unique gene based medicines, both in house and with partners. We drive credible science to realise incredible results. Whether you're motivated by the discovery and development of product candidates within Research..... click apply for full job details