Digital Capability and Data Integrity Lead
Core
Driving site-wide digital transformation and ensuring robust, compliant Data Integrity (DI) practices across all GxP operations in pharmaceutical manufacturing.
Role type
Senior IC Digital Capability & Data Integrity Lead
Builds
Digital solutions including electronic batch records (EBR), LIMS, MES, QMS workflows, IoT sensors, and data analytics platforms
Domain
Pharmaceutical/Biotech manufacturing and GxP compliance
Deliverable
production ML models | product features | infrastructure
Required skills
GxP computerized systems expertise, Data Integrity risk mitigation, Computerized System Validation (CSV), regulatory compliance, digital strategy implementation, change management
Preferred skills
Experience with MES, LIMS, ERP, eQMS, historian, automated controls, capability building
Technologies
EBR, LIMS, MES, QMS, IoT, data analytics platforms
Responsibilities
Partner with leadership to define and implement site digital strategy; Drive adoption of digital solutions; Identify opportunities to reduce manual operations and improve data reliability; Lead local digital projects from concept through validation; Ensure digital solutions meet GxP and cybersecurity requirements
Seniority
Senior, hands-on IC
