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 Engineer (Data Integrity)
Builds
Compliance programs, risk assessments, validation strategies, and training solutions for regulated pharmaceutical manufacturing.
Domain
Pharmaceutical manufacturing / Cell Therapy / GxP Compliance
Required skills
GxP compliance, Data Integrity Risk Assessments (DIRA), Quality Risk Assessments (QRA), Computerized System Validation (CSV), Root Cause Analysis, CAPA/Deviation Management, Internal Audits, Change Control, 21CFR Part 11, SDLC methodologies, Manufacturing Execution Systems (MES), ERP systems, Agile/JIRA
Preferred skills
Organizational Learning & Development, Instructional Design, Adult Learning Principles, Quantitative Research, Digital Transformation, AI-enabled learning solutions, EdD/Doctoral degree
Technologies
ServiceNow, SAP, Oracle, eQMS platforms, Laboratory systems, Electronic Batch Record systems, JIRA
Responsibilities
Lead IT compliance and data integrity programs; Facilitate DIRAs, QRAs, and system impact assessments; Lead investigations, root cause analyses, and CAPA development; Support computerized system validation activities; Conduct compliance assessments and change impact evaluations; Lead internal audits and regulatory inspection readiness; Develop training strategies and learning programs; Mentor team members in compliance and digital transformation.
Seniority
Senior, hands-on IC