AI Consultant – Validation & Life Sciences (Pharmaceutical)
Company: Global Reach
- Location: Switzerland
- Seniority: Senior
- Employment type: Full-time
- Posted: Yesterday
- Offer language: English
Job description
Role purpose:
Bring validation, life-sciences and agent-building expertise to the BIS AI roadmap. The role builds and validates AI agents for R&D, Medical Writing, Regulatory, CMC and Commercial, and builds the finance agents together with the in-house Dynamics 365 lead, who owns the D365 Finance & Operations process and data design. The existing AI and Power Platform developer leads apps, connectors, Azure AI Foundry and integration. This role owns computer system validation (GxP/CSV) and SOX controls for AI tools, business analysis with scientific and finance teams, Copilot Studio agents and Copilot Cowork skills. The company works in a regulated (GxP and SOX) biotech environment on the Microsoft stack: Microsoft 365 Copilot, Copilot Studio, Copilot Cowork, Azure AI Foundry and Dynamics 365.
Key responsibilities:
Build:
- Build and maintain agents in Copilot Studio and Microsoft 365 Copilot for scientific, regulatory, commercial and finance teams
- Author Copilot Cowork skills, instructions and scheduled or event-triggered automations
- Build document-checking agents: drafting clinical documents from tables, listings and figures; checking dossier and report numbers against sources
- Build finance agents on D365 data with the in- house D365 lead, who specifies the finance rules and data
Validate & control:
- Lead computer system validation (CSV) for GxP- relevant AI tools: intended use, URS, risk assessment (GAMP 5), PQ and traceability
- Define SOX IT general controls and evidence for finance agents, interfaces and the AI document-capture solution
- Build evaluation sets and accuracy KPIs; keep validation records up to date after model or prompt changes
- Run user acceptance testing with business owners
Analyse & scope:
- Run discovery workshops with R&D, Medical Writing, Regulatory, CMC, Quality, Commercial and Finance
- Turn requests into scoped use cases with success measures and acceptance criteria
- Assess new use cases for value, GxP impact, data governance and EU AI Act risk class
- Write clear specifications for the developer and partners
Enable & coordinate:
- Train users and support the AI Champions network; publish agent templates and guidelines
- Coordinate external partners on validation and quality
- Report accuracy KPIs and benefits to business owners
- Share one backlog and agent catalogue with the developer and the D365 lead
Experience & qualifications:
- Degree in life sciences, computer science, engineering or similar
- 5+ years in pharma, biotech, medtech or another GxP-regulated company, in IT, quality/CSV or business analysis
- Has written CSV deliverables for computerised systems; SOX controls experience is an advantage
- 1–2+ years building agents or Copilot solutions hands-on (Copilot Studio or similar), ideally used in production
- Dynamics 365 Finance & Operations experience is an advantage
- Desirable certifications: PL-200, PL-900 / AI-900, AI-102; GAMP 5 / CSV training; MB-310
- Languages: fluent English; German is an advantage
