Senior GMP Manufacturing & AI Advisor (remote)

................ 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. Your Tasks: - 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 Your Profile: - 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 requirements - Excellent communication and stakeholder management skills, with the ability to present complex topics to executive audiences - Fluent in English Find Jobs in Switzerland on Arbeitnow