Chief, Computerized Systems QA & Validation (SaMD/AI)

IXICO plc; Greater London; Hybrid; GBP 110,000 - 160,000; Full time

Benefits offered by this job

Generous pension

Private medical insurance

Life assurance 4x salary

25 days annual leave

Employee Benefits Portal

Job summary

IXICO plc seeks a Head of Computerized Systems Quality Assurance & Validation to lead regulatory compliance and validation of computerized systems across the life cycle, including SaMD/AIaMD. The role oversees CSV packages, risk assessments and audits, and advances quality by design in a global neuroscience imaging platform.

The successful candidate will guide policy development, partner with IT and CTO, and ensure adherence to GxP, GDPR, ISO standards and industry best practices.

Qualifications

• Excellent knowledge and experience of computerized system validation in Life Sciences.
• Strong regulatory compliance know‑how for computerized systems including SaMD/AIaMD.
• Solid information security controls and ISO 27001/SOC2 awareness.
• Good written and verbal communication; able to convey complex concepts clearly.
• Proactive, self‑starter with the IXICO values: Accountability, Ability, Agility and Aspiration.

Responsibilities

• Act as SME for regulatory requirements related to computerized systems and SaMD/AIaMD validation.
• Review and approve CSV packages and risk assessments.
• Lead internal audits and supplier assessments for software, cloud, and data hosting.
• Support client and regulatory audits with expert QA input on software validation.
• Drive training on quality and security by design for IXICO staff.

Skills

CSV validation

Regulatory compliance

Information Security

GCP knowledge

AI/ML in SaMD

Communication skills

MS Office

Job description

IXICO plc seeks a Head of Computerized Systems Quality Assurance & Validation to lead regulatory compliance and validation of computerized systems across the life cycle, including SaMD/AIaMD. The role oversees CSV packages, risk assessments and audits, and advances quality by design in a global neuroscience imaging platform.

The successful candidate will guide policy development, partner with IT and CTO, and ensure adherence to GxP, GDPR, ISO standards and industry best practices.