CA

Senior GMP Manufacturing & AI Advisor (remote)

Coopers Group AG•Produktion
ZürichTemps plein100 % télétravailhier

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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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Aperçu du poste

Publiée le
6 novembre 2026
Lieu
Zürich
Type de contrat
Temps plein
Mode de travail
100 % télétravail

Entreprise

CA

Coopers Group AG

Munich
Voir le profil de l’entreprise
Source

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