GxP Systems Quality Lead for AI & Cloud Governance

MindCapture BV; Oost-Vlaanderen; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Meal vouchers

Eco vouchers

DKV health insurance

Group insurance

Net expense allowance

Company car

Training & development

Zusammenfassung

MindCapture BV is seeking a GxP Systems Quality Lead to ensure AI-enabled solutions, cloud environments and computerised systems meet GxP requirements with pragmatic risk-based governance. You will provide QA oversight across lifecycle activities, risk assessments and supplier qualifications within a regulated health-care tech context.

Join a consultancy serving an international market leader in healthcare, shaping QA frameworks, supporting regulatory inspections and guiding IT and cloud

Qualifikationen

• Master’s degree or equivalent in a scientific/engineering/IT field.
• Significant QA experience within a GxP regulated pharma/biotech environment.
• Strong understanding of computerized systems compliance across lifecycle.
• Demonstrated AI experience in a regulated environment (governance, risk, lifecycle).
• IT and cloud infrastructure knowledge with GxP qualification experience.
• Experience with cloud services and service models (SaaS, PaaS, IaaS).
• Familiarity with GAMP 5, EU GMP Annex 11, 21 CFR Part 11 and Data Integrity.
• Experience supporting regulatory inspections and audits.

Aufgaben

• Act as a GxP Systems Quality and QA SME for technology activities.
• Provide independent Quality oversight across lifecycle of GxP systems and infrastructure.
• Assess GxP impact, use, and regulatory requirements of new technologies.
• Provide QA oversight for AI-enabled systems including governance and data integrity.
• Develop risk-based Quality frameworks for AI and emerging tech.
• Oversee IT/cloud infrastructure qualification, cloud services and supplier qualification.
• Collaborate with tech teams on cloud platform implementation with GxP controls.
• Review risk assessments, qualification strategies, changes controls and CAPAs.
• Support supplier assessments for SaaS, cloud, infrastructure and AI providers.
• Assist regulatory inspections and audits as a GxP Systems QA SME.
• Translate emerging regulatory expectations into practical QA requirements.

Kenntnisse

GxP QA expertise

AI governance

Cloud infrastructure

Regulatory compliance

Risk assessment

Stakeholder management

Quality oversight lifecycle

Ausbildung

Master’s degree in science/engineering/IT or related

Tools

GxP compliance tools

Cloud platforms (SaaS/PaaS/IaaS)

Jobbeschreibung

MindCapture BV is seeking a GxP Systems Quality Lead to ensure AI-enabled solutions, cloud environments and computerised systems meet GxP requirements with pragmatic risk-based governance. You will provide QA oversight across lifecycle activities, risk assessments and supplier qualifications within a regulated health-care tech context.

Join a consultancy serving an international market leader in healthcare, shaping QA frameworks, supporting regulatory inspections and guiding IT and cloud