Senior GMP Manufacturing & AI Advisor (remote)

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