Coopers Group AG
9 hours ago
Senior GMP Manufacturing & AI Advisor (remote)
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Company information
- Company
- Coopers Group AG
- Location
- Zürich Germany
- Posted
- 9 hours ago
Job description
................
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
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Required skills
- english
- production
- engineering
- remote
- manufacturing
- quality assurance
- generative ai
- ai
- artificial intelligence
- gxp
- data integrity
- pharmaceutical
- compliance frameworks
- stakeholder management
- zurich
- gmp
- workflow optimization
- document automation
- advisor
- advanced analytics
- animal health
- predictive analytics
- manufacturing sites
- operational readiness
- biotech
- csa
- roadmaps
- executive-level recommendations
- deviation management
- regulatory inspections
- gamp 5
- 21 cfr part 11
- stakeholder interviews
- ms&t
- pilot programs
- alcoa+
- maturity assessments
- eu annex 11
- ai regulations
- decision support systems
- regulated pharmaceutical environments
- regulatory-compliant organization
- pilot locations
- ai deployment strategies
- batch execution
- ai agent solutions
- ai/ml validation
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