Lead Engineer, IT Compliance, Data Integrity
Core
Lead IT compliance and data integrity programs for GxP computerized systems in Cell Therapy manufacturing, quality, and lab operations.
Role type
Senior IC IT Compliance & Data Integrity Engineer
Builds
Compliance programs, risk assessments, validation strategies, and training solutions for pharmaceutical manufacturing
Domain
Pharmaceutical manufacturing / Biologics / GxP / IT Compliance
Required skills
Data Integrity Risk Assessments (DIRA), Quality Risk Assessments (QRA), Root Cause Analysis, CAPA/Deviation Management, Computerized System Validation (CSV), Change Control, Internal Audits, Regulatory Inspection Readiness, cGMP/GxP/GAMP/21CFR Part 11 knowledge, SDLC methodologies, ERP systems, Process Automation, Adult Learning Principles
Preferred skills
Master's/Doctoral degree in Education/Organizational Leadership, Curriculum design, Workforce capability development, AI/Automation for learning
Technologies
ERP systems, Process Automation, Historians, AI tools, Digital training solutions
Responsibilities
Lead DIRAs, QRAs, and system impact assessments; Conduct root cause analyses and deviation management; Support CSV activities throughout system lifecycle; Lead internal audits and regulatory inspection readiness; Develop training strategies and competency frameworks; Partner on digital transformation and AI initiatives; Mentor team members in compliance and learning
Seniority
Senior, hands-on IC