Trainee Associate

IXICO plc (AIM: IXI) is a global leader in neuroscience imaging and biomarker analytics, using its proprietary AI-driven platform to help advance the treatment of neurological disorders and reduce the uncertainties associated with drug discovery, development and monitoring. As a key part of the global neurological disease research community, the Company has built a global reputation and 20-year track record as an end-to-end Imaging Contract Research Organisation (iCRO) working with leading pharma companies, innovative biotech's, disease consortia and non-profit organisations. IXICO has supported hundreds of neurological clinical trials, analysed hundreds of thousands of scans and built an expansive network of expert imaging centres around the world.

The IXICO Platform is tailor-made for neurological disease, reliably processing data from global trials, precisely measuring key imaging biomarkers associated with the identification, progression and treatment of diseases such as Alzheimer's, Huntington's and Parkinson's. Image data is interrogated by the Platform and IXICO's expert scientists translating complex data into clinically meaningful insights while minimizing data variability and increasing reproducibility.

This role provides an important administrative service to the Quality Assurance (QA) function and wider organisation in the implementation, ongoing improvement and effectiveness of the integrated IXICO Management System (IMS).

• Administer IXICO’s electronic Quality Management System (QMS) and provide training and support to staff in the sub-system elements i.e., document management system (DMS) and training management system (TMS).
• 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.
• Deliver staff training in the Deviation and CAPA process.
• Conduct Internal Audits as required in order to ensure compliance with statutory, regulatory and IMS requirements.
• Prepare and present quality KPIs/metrics at IXICO Management Review meetings, Townhalls (all employee) and other departmental meetings.
• Support IXICO's preparations for Client Audits and Regulatory Agency Inspections (including ISO 13485 & ISO 27001 audits), as requested by QA management/leadership.
• Support in the delivery of Quality & Compliance departmental and company objectives.

Meticulous attention to detail, strong focus on quality and drive to identify process improvements are essential. Excellent Microsoft Office package experience and computer literacy are required. The ability to collate, classify and perform simple statistical analysis on information/data is necessary. Previous experience in a professional QA and/or administrative working environment is preferred. Candidates must be able to handle data with confidentiality and have a flexible and adaptive approach towards the requirements of the role.

A Bachelor’s degree (or equivalent) is required, with studies that support successful achievement of this role’s essential duties, responsibilities and company objectives. Previous experience as a quality professional in either the Biopharma, Medical Devices/Diagnostics, clinical research and/or software development/technology industries is advantageous. Experience of using and administrating Document and Training/Learning Management Systems is beneficial. Knowledge and experience of performing internal Quality/Management System Audits, including training and experience of performing GCP, ISO 13485, ISO 9001, and/or ISO 27001 audits is expected. Knowledge of Artificial Intelligence (AI) tools, concepts and their use in business automation, improvements and product development is a plus. Knowledge of Information Technology (IT) and Computerized Systems, including information security and data privacy requirements/methodologies is also important.

Benefits include:

• Staff Annual Bonus Plans and Annual Salary Review.
• Generous employer pension contribution of 6%.
• 25 days annual leave, increasing up to 28 days with every year at IXICO.
• BUPA private medical insurance scheme.
• Life Assurance of 4x annual salary.
• Employee Benefits Portal, offering various discounts in retail, food & drink, and entertainment.
• 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 offering advice and support on a wide range of topics.
• Hybrid working model pattern split between working in the City of London and remotely.
• Reimbursement allowance to purchase equipment to support working from home.
• Generous employee referral scheme offering £2,000 for referring a successful candidate to the company.
• Financial assistance for professional qualifications.

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 motivated Quality Assurance Associate in a permanent full-time capacity to thrive in an engaging and fast-paced environment, to make a difference on an everyday basis.

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.