Senior GMP & AI Advisor | Remote, Strategic Innovation

Jobgether; Nederland; Teletrabalho; EUR 150 000 - 190 000; Tempo parcial

Vantagens oferecidas por esta oferta de emprego

Fully remote work

Independent contractor engagement

AI transformation projects in pharma/β

Senior stakeholder exposure

Resumo da oferta

Partner company in the Netherlands seeks a Senior GMP Manufacturing & AI Advisor to drive compliant AI-enabled improvements in regulated production environments. The role combines strategic consulting with hands-on manufacturing and regulatory expertise, advising senior leadership on AI opportunities, validation, and implementation across GMP sites worldwide.

You will assess processes, identify bottlenecks, and define scalable AI deployment roadmaps while ensuring data integrity and compliance

Qualificações

• 12+ years hands-on GMP manufacturing experience in pharma/biotech.
• Experience in Production, QA, MS&T, or Engineering.
• Proven AI or advanced analytics use cases within GMP environments in last 24 months.
• Expertise in Generative AI and AI agent solutions for GxP processes.
• Strong knowledge of AI validation, data integrity, and pharmaceutical compliance requirements.
• Familiar with GAMP 5, CSA, 21 CFR Part 11, EU Annex 11, and ALCOA+ principles.

Responsabilidades

• Analyze end-to-end vaccine development and manufacturing processes to identify bottlenecks and opportunities for AI adoption.
• Assess AI-driven solutions including predictive analytics, automation, and decision-support.
• Prioritize AI initiatives based on feasibility, value, and impact.
• Support regulatory-compliant AI governance and validation frameworks.
• Assess manufacturing sites for maturity and readiness for AI deployment.
• Define pilot locations and scale-up roadmaps for AI in GMP environments.
• Present strategic recommendations and roadmaps to senior leadership.

Conhecimentos

GMP manufacturing

Pharma/biotech

AI in manufacturing

Regulatory compliance

GxP

Stakeholder management

English fluency

Ferramentas

GAMP 5

CSA

21 CFR Part 11

EU Annex 11

ALCOA+

AI governance

Descrição da oferta de emprego

Partner company in the Netherlands seeks a Senior GMP Manufacturing & AI Advisor to drive compliant AI-enabled improvements in regulated production environments. The role combines strategic consulting with hands-on manufacturing and regulatory expertise, advising senior leadership on AI opportunities, validation, and implementation across GMP sites worldwide.

You will assess processes, identify bottlenecks, and define scalable AI deployment roadmaps while ensuring data integrity and compliance