Analyze the end-to-end autogenous vaccine development process and identify operational bottlenecks, inefficiencies, and decision-making chal
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Warum dieser Job gelistet ist
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Analyze the end-to-end autogenous vaccine development process and identify operational bottlenecks, inefficiencies, and decision-making challenges Assess opportunities for AI-driven solutions, including predictive analytics, document automation, workflow optimization, and decision support systems Develop and prioritize AI initiatives based on feasibility, business value, and implementation potential Support the establishment of a regulatory-compliant organization aligned with current and emerging AI regulations Evaluate manufacturing sites and recommend pilot locations based on maturity assessments and operational readiness Conduct stakeholder interviews and present executive-level recommendations and roadmaps Contribute to the development of pilot programs and scalable AI deployment strategies within GMP-regulated environments
: 12+ years of hands-on GMP manufacturing experience within the pharmaceutical, biotech, or animal health industry Proven operational experience in Production, Quality Assurance, MS&T, or Engineering, including batch execution, deviation management, and regulatory inspections Demonstrated experience delivering AI or advanced analytics use cases within GMP environments during the last 24 months Expertise in Generative AI or AI agent solutions within GxP-regulated processes Strong knowledge of AI/ML validation, data integrity, and compliance frameworks including GAMP 5, CSA, 21 CFR Part 11, EU Annex 11, and ALCOA+ Experience conducting manufacturing site assessments and advising senior leadership teams Up-to-date knowledge of evolving AI-related pharmaceutical regulations and GMP
For our client in Zurich, we are looking for an experienced Senior GMP Manufacturing & AI Advisor (remote). We are looking for an professional who combines deep GMP manufacturing expertise with hands-on experience in Artificial Intelligence within regulated pharmaceutical environments. The ideal candidate will act as a trusted advisor, helping to identify, assess, and implement AI-driven improvements across manufacturing and quality processes.
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