Engineer, IT Compliance
Core
Lead compliance activities for GxP electronic systems and applications, ensuring regulatory and procedural compliance for the site's right to operate.
Role type
Individual contributor IT Compliance Engineer
Builds
Quality Systems deliverables for electronic systems and applications throughout their lifecycle
Domain
Life Sciences / Pharmaceutical / GxP Compliance
Deliverable
dashboards & analysis
Required skills
GxP compliance, Quality Systems (Deviations, CAPAs, Change Requests, SOPs), ALCOA+ principles, global Health Authority regulations, computerized systems (MES, ERP, LIMS, Validation Lifecycle, QMS, LMS), metrics reporting, root cause analysis
Preferred skills
Contract resource management, site integration, enterprise harmonization
Responsibilities
Manage IT metrics reporting linked to regulatory compliance and Quality Events; Perform/lead investigations and root cause analyses for Quality Event deviations; Author/review/approve Quality Systems records; Partner on continuous improvement efforts; Perform periodic reviews of SOPs; Participate in governance boards; Support regulatory inspections as SME; Manage supporting contract resources
Seniority
Mid-level, hands-on IC