Head of Computerized Systems Quality Assurance & Validation

\n Head of Computerized Systems Quality Assurance & Validation\n

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 scans and built an expansive network of expert imaging centres around the world.

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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 while minimizing data variability and increasing reproducibility.

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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.

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To help us deliver our medical image analysis solutions to large clinical trials we are hiring a Head of Computerized Systems Quality Assurance & Validation on a permanent full-time capacity.

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Purpose of the Role:

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This role supports the compliant and timely design/development, testing, verification, validation, configuration, and life cycle management of computerized systems (including software) developed, purchased and/or utilised by IXICO. This role supports the drafting, review & approval of software development and validation policies and procedures, ensuring best practice for ‘security & privacy by design’ principles and in compliance with current GCP, FDA 21 CFR Part 11, EU Annex 11, GAMP, FDA QSR Part 820 (QMSR), EU MDR (Regulation 2017/745), IEC 62304, GDPR, ISO 13485, ISO 27001 and ISO 42001/EN 18286 regulatory & management system requirements.

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Essential Duties and Responsibilities:

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• Act a subject matter expert (SME) for regulatory requirements related to computerized systems, directing IXICO teams on the minimum requirements for regulatory compliance and suggested best practice.
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• Ensure policies and procedures reflect current regulatory requirements and best practice; monitor and plan for future proposed changes in regulations, standards and official guidance documents relating to all stages of the computerized systems lifecycle, including software as a Medical Device (SaMD), AI as a Medical Device (AIaMD) validation and operation including information privacy and security requirements.
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• Review and approve computerized system risk assessments (including as per ISO 14971& AI standards) and categorisation of software per regulatory requirements.
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• Review and approve Computerized System Validation (CSV) packages, as an independent QA approver.
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• Review and support the compliant and pragmatic resolution of validation events/failures, ensuring required records are maintained.
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• Maintain awareness in developments in Artificial Intelligence (AI) and Machine Leaning (ML), including Generative AI, Agentic AI and Large Language Models (LLM) and their use in the development of IXICO computerized systems and products/services. Ensure the IXICO Management System incorporates regulatory requirements for use and oversight of such AI tools.
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• Develop and implement training materials on best practices in ‘quality & security by design’ and validation requirements for computerized systems and provide ongoing coaching to IXICO staff.
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• Plan and perform Internal Audits in compliance with ISO Management System Requirements and the IXICO Internal Audit programme.
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• Assess (including via audit) and approve external suppliers/subcontractors of computerised systems, including software, Cloud and data hosting providers. Working with the relevant business owner, determine the necessary requirements for system validation & acceptance. Review and approve CSV packages for external off-the-shelf software, including the review of supplier provided validation documentation, and ongoing version release validation.
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• Act a subject matter expert (SME) for regulatory requirements and support CSV related to integrations with 3rd party platforms.
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• Oversee the process of periodic review of computerized systems and coordinate with Business/System owners to complete such reviews in compliance with regulatory and management system requirements.
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• Oversee the process for maintaining up to date inventories of computerized systems, working with functional areas to update as required.
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• Support IXICOs preparations for Client Audits, Certification Body Audits and Regulatory Agency Inspections; act as an SME for software validation requirements during such audits.
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• Review and complete client questionnaires regarding information security/privacy and computerized systems topics.
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• Working with the Head of IT and CTO, support effective and efficient penetration testing, data backup and restore strategies; play a leading role in IXICO disaster recover planning and business continuity testing.
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• Support in the delivery of Quality & Compliance departmental and company objectives.
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Qualifications and skills required for the role:

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• Excellent knowledge and experience of computerized system validation gained within the Life Sciences industry.
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• Excellent knowledge and experience of Information Security requirements & controls (ISO 27001 / SOC2).
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• Knowledge of SaMD regulatory requirements, including the integration of AI & ML into SaMD.
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• Self-starter, organised with a character aligned to IXICO’s core values of Accountability, Ability, Agility and Aspiration.
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• Excellent Microsoft Office package experience and computer literacy.
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• Good written and verbal communication skills.
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• Multi-tasker, organised and able to manage time efficiently.
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• Detail and task oriented, with a strong focus on quality and attention to detail.
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• Previous experience as a quality professional in either the Biopharma, Medical Devices/Diagnostics and/or clinical research industry.
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• Good understanding of Good Clinical Practice (GCP) and associated clinical trials regulations.
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• Knowledge of medical device design control requirements.
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• Staff Annual Bonus Plans and Annual Salary Review.
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• Generous employer pension contribution of 6%.
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• 25 days annual leave, increasing up to 28 days with every year at IXICO.
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• BUPA private medical insurance scheme.
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• Life Assurance of 4x annual salary.
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• Employee Benefits Portal, offering various discounts in retail, food & drink, and entertainment.
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• Engaging and social environment, with fundraising and sporting activities and seasonal events such as Summer and Christmas parties.
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• Wellbeing initiatives such as eye tests, flu jabs, and Mental Health Awareness Training.
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• Employee Assistance Programme offering advice and support on a wide range of topics.
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• Hybrid working model pattern split between working in the City of London and remotely.
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• Reimbursement allowance to purchase equipment to support working from home.
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• Generous employee referral scheme offering £2,000 for referring a successful candidate to the company.
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• Financial assistance for professional qualifications.
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• Opportunity to contribute to an industry where your work has an impact every single day.
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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.

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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.

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This is a great opportunity for a motivated Head of Computerized Systems Quality Assurance & Validationin a permanent full-timecapacityto thrive in an engaging and fast-paced environment, to make a difference on an everyday basis.

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