CA
Senior GMP Manufacturing & AI Advisor (remote)
Coopers Group AG
Contract type
Ongoing
Work mode
Remote · Zürich
Experience
Lead / principal · 12+ years
Job description
A senior advisory role for an experienced GMP manufacturing professional with hands-on AI experience in regulated pharmaceutical environments, acting as a trusted advisor to identify, assess and implement AI-driven improvements across manufacturing and quality processes.
At a glance
- Work mode
- Remote · Zürich
- Languages
- English – fluent
What you'll do
- 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
What we're looking for
- 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