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