Quality System Manager

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

Step into a GxP Systems Quality Lead role where Quality expertise meets emerging technology. You will help ensure AI enabled solutions, cloud environments and computerised systems are implemented and governed in line with GxP requirements while enabling pragmatic, risk based ways of working.

We offer competitive salaries, a full benefits package (meal vouchers, eco vouchers, DKV health insurance, group insurance, net expense allowance and a company car). You also get the opportunity to shape your future through personalised training and development.

At MindCapture, you choose what you love, build on your strengths and make a difference where it matters most.

You will work as a MindCapture consultant for an international market leader in the healthcare industry.

Job Description:

• Act as a GxP Systems Quality and QA Subject Matter Expert for technology related activities
• Provide independent Quality oversight throughout the lifecycle of GxP computerised systems, technology solutions and supporting infrastructure
• Assess the GxP impact, intended use and regulatory requirements of new and existing technologies
• Provide Quality oversight for AI enabled systems and use cases, covering risk classification, governance, data integrity, traceability, supplier considerations, lifecycle controls and regulatory compliance
• Support the development and implementation of risk based Quality frameworks for AI and other emerging technologies
• Provide Quality oversight for IT and cloud infrastructure, including infrastructure qualification, cloud services, platform changes, supplier qualification and shared responsibility models
• Partner with technology teams on the implementation and evolution of cloud platforms and services while ensuring appropriate GxP controls
• Review and approve risk assessments, qualification and validation strategies, change controls, deviations and periodic reviews from a QA perspective
• Provide QA oversight for changes, incidents, deviations and CAPAs related to computerised systems and technology infrastructureContribute to policies, SOPs, standards and governance covering GxP systems, AI, infrastructure and computerised systems
• Ensure compliance with applicable GxP requirements, 21 CFR Part 11, EU GMP Annex 11, GAMP 5 and Data Integrity principles
• Provide Quality input into supplier assessments for SaaS, cloud, infrastructure and AI technology providers
• Support regulatory inspections and internal and external audits as a GxP Systems Quality Subject Matter Expert
• Monitor emerging regulatory expectations and translate them into practical Quality requirements

Requirements:

• Master’s degree in a scientific, engineering, IT or related discipline, or equivalent experience
• Significant Quality Assurance experience within a GxP regulated pharmaceutical or biotech environment
• Strong understanding of computerised systems compliance and Quality oversight throughout the system lifecycle
• Demonstrated expertise in AI within a regulated environment, ideally covering governance, risk assessment, lifecycle management or Quality oversight of AI enabled solutions
• Strong knowledge of IT and cloud infrastructure with an understanding of GxP compliance and qualification requirements
• Experience with cloud technologies and service models including SaaS, PaaS and IaaS
• Strong knowledge of GAMP 5, EU GMP Annex 11, 21 CFR Part 11, Data Integrity principles and relevant GxP requirements
• Experience providing QA oversight for changes, deviations, CAPAs, periodic reviews and supplier qualification related to computerised systems
• Ability to assess emerging technologies from a Quality and risk perspective using pragmatic, risk based approaches
• Experience collaborating with IT teams, system owners, business stakeholders and technical Subject Matter Experts
• Experience with modern technology environments, data platforms, cloud technologies or infrastructure is preferred
• Experience supporting regulatory inspections and audits related to computerised systems or technology solutions is preferred
• Strong stakeholder management skills with the confidence to challenge constructively and make pragmatic Quality decisions
• Comfortable working in a rapidly evolving environment where processes and governance continue to develop
• Fluent in English

Are you ready to make a real difference in healthcare?

Join our dynamic team and help drive innovation in medical devices.