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

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