Senior Consultant IT Quality & CSV / Life Sciences (m/w/d)
Core
Develop innovative regulatory and compliance solutions for Life Sciences clients, focusing on IT Quality, GxP system validation, and AI validation in regulated environments.
Role type
Senior Consultant, Regulatory & Compliance Advisory
Builds
Individual solution approaches for Pharma and MedTech clients regarding digital transformation and compliance
Domain
Life Sciences (Pharma, MedTech) + Regulatory Compliance + IT Systems
Deliverable
client delivery
Required skills
GxP validation & qualification, EU-GMP knowledge (Chapters 4, 11, 15, 22), Computer System Validation (CSV) methods, V-Modell, Agile validation, GAMP 5, IT system knowledge (eQMS, RIMS, ERP, MES, LIMS, CRM, eDMS), Regulatory Affairs processes, Data integrity, Audit Trail
Preferred skills
Life Science degree (Pharmacy, Biotechnology, Chemistry, Bioinformatics), Experience with SAP & SaaS solutions, AI/Agentic AI validation, Humanoid robots in GxP
Technologies
SAP, SaaS, eQMS, RIMS, ERP, MES, LIMS, CRM, eDMS
Responsibilities
Advise Life Science companies on IT Quality Management and GxP system validation; Analyze, implement, and optimize GxP processes and IT systems; Conduct IT system validations (specifications, risk assessment, tests, documentation); Work on innovation topics like AI validation and humanoid robots in GxP
Seniority
Senior, hands-on IC