Quality System Manager

MindCapture BV; Oost-Vlaanderen; In loco; EUR 90.000 - 130.000; Tempo pieno

Vantaggi offerti da questo lavoro

Meal vouchers

Eco vouchers

DKV health insurance

Group insurance

Net expense allowance

Company car

Training & development

Descrizione del lavoro

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

Competenze

• 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.

Mansioni

• 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.

Conoscenze

GxP QA expertise

AI governance

Cloud infrastructure

Regulatory compliance

Risk assessment

Stakeholder management

Quality oversight lifecycle

Formazione

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

Strumenti

GxP compliance tools

Cloud platforms (SaaS/PaaS/IaaS)

Descrizione del lavoro

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 infrastructure
• Contribute 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?

If MindCapture sees a potential fit, we’ll get in touch as soon as possible.

If you don’t hear from us within two weeks, it simply means that this particular position wasn’t the right match. In that case, we’ll gladly keep your profile in mind for future roles that could suit you better.