Advanced analytics. Intelligent insights.
IXICO plc (AIM: IXI), is a leading neuroimaging Contract Research Organization (CRO), delivering advanced Ai analytical insights in neuroscience to the global clinical trials market. Established in 2004, listed as a public company in 2013, IXICO has firmly established itself as a trusted partner to the global life sciences industry, supporting the development of new therapies for neurological conditions such as Alzheimer’s, Parkinson’s, Huntington’s Disease and Multiple Sclerosis.
With our focus on neuroscience, our purpose is to advance human health by turning data into clinically valuable insights; helping our clients reduce clinical development risk and improve return on investment from their clinical development programmes. We achieve this by combining Ai machine learning imaging biomarker analysis, together with centralised neuroimaging CRO services to provide an integrated service covering every stage of clinical development through to post-marketing surveillance. We are committed to invest in continuously enhancing our validated and peer reviewed disease optimised machine learning Ai analytics services and our infrastructure and technology to support our ambitious growth strategy. Our people are empowered to enable us to achieve our company goals and their own personal development through the “4A” values at the heart of our culture: Aspiration, Ability, Agility and Accountability.
To help us deliver our medical image analysis solutions to large clinical trials we are hiring a dedicated Quality Assurance Coordinator in a full-time capacity.
Essential Duties and Responsibilities:
- Lead in enhancing IXICO’s Quality Culture, including:
- Acting as a ‘Quality Ambassador’ internally and externally for IXICO
- Proactively communicating the IXICO Quality Policy to ensure that the Quality Policy is understood by all staff.
- Promoting, leading and participating in continual improvement activities/projects
- Assisting in the identification and management of risks and supporting the delivery of effective Preventive Actions.
- Log Deviations (nonconformities), assist with deviation investigations, and manage deviations to ensure Corrections, Corrective Actions and Preventive Actions are appropriately documented, effective and timely. Provide input and KPIs/metrics to the management review process. Deliver staff training in the Deviation and CAPA process.
- Act as subject matter expert (SME) for Good Clinical Practice (GCP) ensuring that the IXICO Management System (IMS) continually meets all applicable GCP requirements. Develop and deliver Quality System/GCP new-starter and refresher staff training.
- Continual improvement – lead and facilitate continual improvement projects across the business to further improve the IMS, operational efficiencies and client satisfaction.
- Support the change management process, providing guidance to staff and review/approval of change from a Quality perspective.
- Prepare and provide KPIs/metrics in order to develop, maintain and improve the integrated IXICO Management System; prepare and present quality KPIs/metrics at IXICO Management Review meetings, Townhalls (all employee) and other departmental meetings.
- Support IXICOs preparations for Client Audits and Regulatory Agency Inspections as requested by the SVP Quality & Compliance.
- Conduct Internal Audits as required in order to ensure compliance with statutory, regulatory and IXICO management system requirements.
- Conduct supplier (vendor) and subcontractor assessments/audits as required in order to evaluate, select and monitor IXICO suppliers and subcontractors.
- Administer IXICO’s electronic Management System (TrackWise Digital) and provide training and support to staff in the sub-system elements i.e., document management system (DMS), and training management system (TMS). Maximise the use of capabilities available within TrackWise such that TrackWise increases the efficiency and effectiveness by which QMS is delivered within IXICO.
- Administer and monitor the DMS and coordinate the periodic reviews of IMS documents with applicable areas as per schedule, ensuring any updates happen by the cycle review date.
- Administer and monitor the TMS to ensure that staff training is documented and occurs as per schedule; prepare and present training system performance KPIs/metrics.
- Participate in identification and recording of risks as per the Risk Management process; Support the identification and implementation of Improvement and Preventive Actions in order to treat and minimise risks; develop and deliver Risk Management staff training.
- Administer the ‘Request for Information’ (RFI) process, working closely with Business Development and all IXICO functions to ensure the timely and accurate response to potential new & existing client information requests.
- Support in the delivery of Quality & Compliance departmental and company objectives.
- Strong ongoing awareness and understanding of applicable policies and procedures as defined in the employee training plan: including but not limited to IXICO’s Quality Policy, Information Security Policy, Personal Information Management System Policy; ensure awareness of responsibilities under IXICO’s policies and procedures.
Qualifications and skills:
- Self-starter, organised with a character aligned to IXICO’s core values of Accountability, Ability, Agility and Aspiration.
- Bachelor’s degree or equivalent in a relevant field.
- Previous experience as a quality professional in either the Biopharma, Medical Devices/Diagnostics and/or clinical research industry.
- Good understanding of Good Clinical Practice (GCP) and associated clinical trials regulations.
- Excellent MS Office package experience.
- Ability to collate, classify and perform simple statistical analysis on information/data.
- Good written and verbal communication skills.
- Multi-tasker, organised and able to manage time efficiently.
- Detail and task oriented, with a strong focus on quality.
- Previous experience in a professional working environment.
- Experience of maintaining and continually improving Quality Management Systems.
- Knowledge and experience of performing internal Quality/Management System Audits and external supplier/subcontractor quality audits, including training and experience of performing GCP, ISO 13485, ISO9001, and/or ISO 27001 audits.
- Experience of co-ordinating external/client audits and regulatory inspections.
- Experience of Clinical Trials and Imaging (MRI/PET).
- Knowledge of Information Security/Information Privacy/GDPR requirements and systems.
- Knowledge of the Honeywell Sparta Systems electronic TrackWise Digital system.
- 25 days annual leave, increasing up to 28 days with every year at IXICO.
- BUPA private medical insurance scheme.
- Hybrid working model.
- Life Assurance of 4x annual salary.
- Staff Annual Bonus Plans and Annual Salary Review.
- Employer pension contribution of 6%.
- Employee Benefits Portal offering various discounts in entertainment, retail, travel and supermarkets.
- Engaging and social environment, with fundraising and sporting activities and seasonal events such as Summer and Christmas parties.
- Wellbeing initiatives such as eye tests, flu jabs, and Mental Health Awareness Training.
- Employee Assistance Programme (EAP), including confidential counselling support.
- Reimbursement allowance to purchase equipment to support working from home.
- Employee referral scheme offering £2,000 for referring a successful candidate to the company.
- Financial assistance for professional qualifications.
- A company in an industry where your work has an impact every single day.
How to Apply
IXICO is working hard to create a representative, inclusive and empowered team, because we believe different experiences, perspectives and backgrounds make a better workplace, and ultimately better services.
IXICO doesn’t discriminate on the basis of race, colour, religion or belief, gender, national origin, age, sexual orientation, marital status, disability or any other protected class.
This is a great opportunity for a dedicated Quality Assurance Coordinator to thrive in an engaging environment and to make a difference on an everyday basis.
If you think IXICO should meet you, please send us your CV and covering letter by email to firstname.lastname@example.org or apply directly via LinkedIn. We are looking forward to your application.
Please note that our entire business is operating under a hybrid working model, where UK-based employees are required to attend our London office 2 days a week. If you have got any questions, please reach out to our careers team.