Manager Analytics and Data Integrity
Core
Lead site analytics web and data quality initiatives to ensure data in GxP systems are connected, accurate, secure, and compliant with global regulatory standards.
Role type
Manager, Analytics and Data Integrity
Builds
Data governance frameworks, analytical models, dashboards, and KPIs for pharmaceutical operations.
Domain
Pharmaceutical manufacturing and regulatory compliance
Deliverable
dashboards & analysis
Required skills
Data governance, regulatory compliance (FDA, EMA, MHRA, GxP), data lifecycle management, risk management, team leadership, project management, change management
Preferred skills
Experience with electronic document management, laboratory information management systems, ALCOA+ principles
Technologies
Enterprise-approved analytics platforms, electronic document management systems, laboratory information management systems
Responsibilities
Implement and maintain Data Integrity compliance activities across the product lifecycle; Establish data mapping and monitor data lifecycle; Collaborate with stakeholders to integrate analytics into decision-making; Lead development of advanced analytical models and tools; Oversee delivery of dashboards and business insights; Represent the site during regulatory inspections; Manage remediation efforts based on risk management principles; Manage and guide a team of employees.
Seniority
Manager, strategic leadership and team management