Kiki Stein

AVAILABLE IMMEDIATELY FOR CONTRACT, CONTRACT-TO-HIRE, AND FULL-TIME OPPORTUNITIES. OPEN TO REMOTE, HYBRID, AND ON-SITE ENGAGEMENTS. Senior Computer Systems Validation (CSV), Computer Software Assurance (CSA), Digital Validation, and Quality Compliance leader with 27+ years of experience supporting pharmaceutical, biotechnology, and medical device organizations in highly regulated GxP environments. I specialize in enterprise validation strategy across SAP ecosystems (S/4HANA, ECC, GRC, Fiori), Veeva Vault platforms, serialization and traceability systems, cloud-based regulated applications, and digital validation solutions supporting global manufacturing and quality operations. My expertise includes FDA 21 CFR Part 11, Parts 210, 211, and 820, GAMP 5, ISO 13485, ISO 14971, ALCOA+ data integrity principles, and risk-based CSA methodologies, with a strong focus on inspection readiness, audit defense, validation governance, and continuous compliance. I have led validation transformation initiatives that modernize CSV programs into risk-based CSA frameworks aligned with Pharma 4.0 and digital validation strategies. I leverage technology, automation, and AI-assisted validation approaches to support risk assessments, traceability, validation documentation, testing activities, and lifecycle management while maintaining GxP compliance and human oversight. Core Areas of Expertise • Enterprise Validation Strategy & Governance • Digital Validation Transformation • SAP S/4HANA & Veeva Vault Validation • Validation Lifecycle Management (VLM) • Serialization & Supply Chain Systems • Cloud / SaaS Validation • Risk-Based Validation (CSA / GAMP 5 / FMEA) • FDA / EMA Inspection Readiness • Data Integrity & Quality Compliance • AI-Assisted Validation & Process Optimization I have partnered with Quality, IT, Manufacturing, Engineering, Supply Chain, and Regulatory Affairs teams to deliver scalable validation solutions and ensure compliance across global operations. Languages: English, Greek, Italian, French, Spanish Seeking senior leadership opportunities in CSV, CSA, Digital Validation, Validation Strategy, and Quality Compliance within life sciences organizations. Open to opportunities across the United States, including North Carolina, Florida, and remote roles. Top Skills: CSV | CSA | Digital Validation | SAP S/4HANA Validation | Veeva Vault Validation | FDA 21 CFR Part 11 | GAMP 5 | GxP Compliance | Data Integrity (ALCOA+) | Risk-Based Validation | AI-Assisted Validation | Pharma 4.0