Digital Quality, MES/Recipe CVS Lead
Core
Drive global harmonization of MES standards and Master Batch Record (MBR) recipes across a manufacturing network while providing expert Computerized System Validation (CSV) guidance for data products and AI/ML models.
Role type
Senior Digital Quality Lead (CSV/MES)
Builds
Global MES standards, MBR recipes, validation documentation for computerized systems, data lakes, and AI/ML models.
Domain
Pharmaceutical/Biotech manufacturing, Computerized System Validation (CSV), Data Integrity
Deliverable
production ML models | product features | dashboards & analysis
Required skills
Computerized System Validation (CSV), MES/eBR/Recipe management, Global GMP regulations (FDA, Swissmedic), Data quality standards, Root cause analysis, Risk management, Validation planning, Data lake architectures
Preferred skills
AI/ML model setup, Advanced technical certification
Technologies
MES platforms, Data lakes, Validation tools
Responsibilities
Drive implementation of global MES standards and MBR recipe harmonization; Create and maintain validation and implementation plans; Ensure qualification and validation documentation adheres to quality standards; Act as the voice of QA in cross-functional teams for data quality strategy; Serve as quality expert for data product implementations and coach teams on AI/ML compliant delivery; Act as subject matter expert for MES/eBR/Recipe setup; Review and approve technical documentation and regulatory responses; Lead root cause analysis and corrective actions for quality gaps; Maintain project CSV deliverables and interface with quality stakeholders.
Seniority
Senior, hands-on IC with strategic planning
