Sr. Security Compliance Analyst
Core
Ensure systems Astellas buys, builds, and runs are secure from the start, including third-party, cloud, and AI solutions.
Role type
Senior Security Compliance Analyst
Builds
Secure third-party and cloud (SaaS) solutions, in-house built applications, and AI systems for GxP and non-regulated use
Domain
Life sciences / Cybersecurity / AI
Deliverable
production ML models
Required skills
Security requirements definition, vendor and cloud service assessment, GxP compliance (21 CFR Part 11, EU Annex 11), risk register management, OneTrust workflows, security frameworks (NIST CSF, ISO 27001)
Preferred skills
GxP environment experience (CSV, GAMP 5), OneTrust/ALM/Veeva Vault, AI risk assessment, secure development (NIST SSDF), supply chain risk (NIST SP 800-161), CRISC/CISA/CISM/CISSP/CCSP/CTPRP certifications
Technologies
OneTrust, NIST CSF, NIST SP 800-53, ISO 27001, 21 CFR Part 11, EU Annex 11, GAMP 5, NIST SSDF, NIST SP 800-161
Responsibilities
Identify security and compliance risks in new projects; assess vendors and cloud services before contracts; review specifications and test evidence for security compliance; run periodic reviews of live systems and vendors; maintain the technology risk register; guide and train system owners and vendors
Seniority
Senior, hands-on IC
