Senior IT Infrastructure & Security Manager Full Time

Role Overview

Lead end-to-end IT operations across Azure, Microsoft 365, AWS, ensuring secure, scalable, and audit-ready systems aligned with ISO 27001, GxP, 21 CFR Part 11, and EU Annex 11.

Key Responsibilities

• Manage cloud infrastructure, network security, DR/BCP, and IT service desk
• Drive ISO 27001 ISMS, audits (FDA/EMA), risk & vulnerability management
• Oversee CSV/CSA for validated systems (ARGUS, ARISg, VigiBase)
• Lead IT asset lifecycle, vendor management, and IT governance
• Implement AI governance & automation (RPA, AI tools) in regulated environments
• Manage IT team, budget, and strategic roadmap
• Define, implement, and enforce enterprise-wide IT governance frameworks, policies, and standards aligned with regulatory and business requirements.
• Ensure compliance with data privacy regulations (GDPR, HIPAA) and collaborate with legal/DPO on data protection strategies, data classification, and cross-border data handling.
• Partner with senior leadership to align IT strategy with business goals, regulatory priorities, and organizational growth plans.

Required Experience

• 8–12 years in IT, with 5+ years in pharma/life sciences/CRO
• Strong expertise in ISO 27001, GxP, cloud security, IT audits
• Hands-on experience with Azure, O365, AWS, endpoint security, SIEM
• Experience in CSV/CSA, IT compliance, and regulatory inspections

Certifications (Preferred)

• ISO 27001 Lead Implementer/Auditor (mandatory), CISSP, CISM, CISA, CCSP, ITIL, Azure Security, AI Governance

Bonus

• Exposure to AI governance, automation, and emerging tech in regulated environments