Head of Computerized Systems QA & Validation (Hybrid)

IXICO; England; Hybrid; GBP 90,000 - 130,000; Full time

Benefits offered by this job

BUPA private medical insurance

Generous pension contributions

25 days annual leave

Job summary

IXICO plc, a global leader in neuroscience imaging, is seeking a Head of Computerized Systems Quality Assurance & Validation in the UK for a permanent full-time role. You will lead regulatory compliance, CSV package reviews, and lifecycle management of computerized systems, including SaMD/AI, ensuring security by design.

This hybrid role splits time between the City of London and remote work, with responsibilities spanning audits, supplier qualification, training, and continuous improvement

Qualifications

• Excellent knowledge and experience of computerized system validation within the Life Sciences industry.
• Excellent knowledge and experience of Information Security requirements & controls (ISO 27001 / SOC2).
• Knowledge of SaMD regulatory requirements, including the integration of AI & ML into SaMD.
• Self-starter, organised with accountability and agility.
• Excellent Microsoft Office package experience.
• 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 as a quality professional in Biopharma/Medical Devices/Clinical research.
• Good understanding of GCP and associated clinical trials regulations.
• Knowledge of medical device design control requirements.
• 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.
• 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.

Responsibilities

• 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.
• 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.
• Review and approve computerized system risk assessments (including as per ISO 14971& AI standards) and categorisation of software per regulatory requirements.
• Review and approve Computerized System Validation (CSV) packages, as an independent QA approver.
• Review and support the compliant and pragmatic resolution of validation events/failures, ensuring required records are maintained.
• 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.
• 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.
• Plan and perform Internal Audits in compliance with ISO Management System Requirements and the IXICO Internal Audit programme.
• 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.
• Act a subject matter expert (SME) for regulatory requirements and support CSV related to integrations with 3rd party platforms.
• 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.
• Oversee the process for maintaining up to date inventories of computerized systems, working with functional areas to update as required.
• Support IXICOs preparations for Client Audits, Certification Body Audits and Regulatory Agency Inspections; act as an SME for software validation requirements during such audits.
• Review and complete client questionnaires regarding information security/privacy and computerized systems topics.
• 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.
• Support in the delivery of Quality & Compliance departmental and company objectives.

Skills

Regulatory compliance

GxP QA

ISO 27001

AI/ML in SaMD

Microsoft Office

Tools

CSV validation tools

Job description

IXICO plc, a global leader in neuroscience imaging, is seeking a Head of Computerized Systems Quality Assurance & Validation in the UK for a permanent full-time role. You will lead regulatory compliance, CSV package reviews, and lifecycle management of computerized systems, including SaMD/AI, ensuring security by design.

This hybrid role splits time between the City of London and remote work, with responsibilities spanning audits, supplier qualification, training, and continuous improvement