Engineer, IT Compliance
Core
Lead compliance activities for GxP electronic systems and applications, ensuring regulatory and procedural compliance to support 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
Required skills
GxP regulations, Quality Systems (Deviations, CAPAs, Change Requests, SOPs), ALCOA+ principles, electronic records/signatures, global Health Authority regulations, metrics reporting, computerized systems (MES, ERP, LIMS, QMS)
Preferred skills
Validation Lifecycle / Testing Software, Learning Management System
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