Design and oversee SAS Viya platform architecture in regulated clinical environments, ensuring GxP compliance, 21 CFR Part 11 readiness, scalability, and validation alignment.
Key Responsibilities
• Design cloud-native architectures (Azure/AWS/GCP) using Kubernetes and IaC
• Architect segregated environments (Dev/Qual/Prod) for validation lifecycle support
• Define security, audit trail, and electronic signature frameworks per 21 CFR Part 11
• Lead CAS performance tuning and HA/DR architecture with defined RPO/RTO
• Author HLD/LLD and validation deliverables (IQ/OQ/PQ traceability)
• Collaborate with Quality Assurance on GxP compliance and inspection readiness
Required Skills
• SAS Viya 4 architecture, CAS, SAS Environment Manager
• Kubernetes, Docker, Helm, AKS/EKS/GKE, OpenShift
• Azure/AWS/GCP networking, identity, and compliance services
• 21 CFR Part 11, GxP (GCP/GLP), CSV, ALCOA+
• CDISC SDTM/ADaM, EDC integrations (Rave, Veeva Vault)
• OAuth2, SAML, LDAP, Active Directory, audit logging