GxP Quality Lead for AI & Cloud Systems

MindCapture BV; Oost-Vlaanderen; Sur place; EUR 90 000 - 120 000; Plein temps

Avantages offerts par ce poste

Meal vouchers

Eco vouchers

Health insurance

Group insurance

Expense allowance

Company car

Training & development

Résumé du poste

MindCapture BV is seeking a GxP Systems Quality Lead to ensure AI-enabled solutions, cloud environments and computerised systems align with GxP requirements. You will provide independent QA oversight across lifecycle stages and collaborate with IT teams to maintain governance and data integrity.

The role emphasizes risk-based quality frameworks for AI, supplier qualification, and regulatory compliance, with a focus on 21 CFR Part 11, EU GMP Annex 11, and data integrity principles.

Qualifications

• Master’s degree in a scientific, engineering, IT or related discipline.
• Significant Quality Assurance experience within a GxP regulated pharmaceutical or biotech environment.
• Strong understanding of computerised systems compliance and lifecycle QA.
• Demonstrated expertise in AI within a regulated environment, ideally governance, risk assessment or lifecycle management.
• Strong knowledge of IT and cloud infrastructure with GxP compliance and qualification requirements.
• Fluent in English.

Responsabilités

• Act as a GxP Systems Quality and QA SME for technology related activities.
• Provide independent Quality oversight throughout the lifecycle of GxP computerised systems and infrastructure.
• Assess GxP impact, use and regulatory requirements of new technologies.
• Provide Quality oversight for AI-enabled systems covering governance, data integrity, traceability and supplier considerations.
• Support risk-based Quality frameworks for AI and emerging tech.
• QA oversight for IT and cloud infrastructure including qualification and changes.
• Collaborate with technology teams on cloud platforms while ensuring GxP controls.
• Review and approve risk assessments, validation strategies, change controls and deviations.
• Provide QA oversight for CAPAs and supplier qualification related to computerised systems.
• Contribute to policies, SOPs, standards and governance for GxP systems and AI.
• Ensure compliance with GxP requirements and data integrity principles.
• Provide QA input into supplier assessments for SaaS, cloud, infrastructure and AI providers.
• Support regulatory inspections and audits as a GxP Systems Quality SME.
• Monitor regulatory expectations and translate them into practical Quality requirements.

Connaissances

GxP quality oversight

AI governance

Regulatory compliance

Stakeholder management

Quality Assurance

Formation

Master’s degree in scientific/engineering/IT

Description du poste

MindCapture BV is seeking a GxP Systems Quality Lead to ensure AI-enabled solutions, cloud environments and computerised systems align with GxP requirements. You will provide independent QA oversight across lifecycle stages and collaborate with IT teams to maintain governance and data integrity.

The role emphasizes risk-based quality frameworks for AI, supplier qualification, and regulatory compliance, with a focus on 21 CFR Part 11, EU GMP Annex 11, and data integrity principles.