Quality Assurance 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.

To help us deliver our medical image analysis solutions to large clinical trials we are hiring a Quality Assurance Associate on a permanent full-time capacity.

Purpose of the Role: 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).

Essential Duties and Responsibilities:

• 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 DMS and coordinate the periodic reviews of IMS documents with applicable functions 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.
• Coordinate the preparation, approval and maintenance of departmental training plans.
• Log Deviations (nonconformities), assist with deviation investigations, and manage deviations to ensure Corrections, Corrective Actions and Preventive Actions (CAPA) are appropriately documented.
• Provide input and KPIs/metrics to the management review process.
• 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 provide KPIs/metrics 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.
• 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 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.

Qualifications and skills required for the role:

• Meticulous attention to detail, strong focus on quality and drive to identify process improvements.
• Excellent Microsoft Office package experience and computer literacy.
• 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 and attention to detail.
• Previous experience in a professional QA and/or administrative working environment.
• Ability to handle data with confidentiality.
• Ability to work autonomously and prioritise workload effectively.
• Flexible and adaptive approach towards the requirements of the role.
• Bachelor’s degree (or equivalent), with studies that support successful achievement of this role’s essential duties, responsibilities and company objectives.
• Character aligned to IXICO’s core values of Accountability, Ability, Agility and Aspiration.
• Previous experience as a quality professional in either the Biopharma, Medical Devices/Diagnostics, clinical research and/or software development/technology industries.
• Good understanding of Good Clinical Practice (GCP) and associated clinical trials regulations.
• Experience of using and administrating Document and Training/Learning Management Systems.
• 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.
• Knowledge of Artificial Intelligence (AI) tools, concepts and their use in business automation, improvements and product development.
• Knowledge of Information Technology (IT) and Computerized Systems, including information security and data privacy requirements/methodologies.

Benefits:

• 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.
• Opportunity to contribute to an industry where your work has an impact every single day.

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.