Biologe (m/w/d)
Core
Leading the Data Governance team to establish and evolve site-wide structures for Data Integrity, Data Security, and Data Life Cycle Management in a regulated pharmaceutical environment.
Role type
Senior management-level Data Governance Team Lead
Builds
Regulatory-compliant data governance frameworks and processes for computerized systems and GxP-relevant data
Domain
Pharmaceutical industry / Regulatory Compliance / Data Integrity
Required skills
Data Governance, Data Integrity, Data Security, Data Life Cycle Management, GxP compliance, Computerized System Validation (CSV), GAP analysis, Audit support, CAPA management, Risk-based Quality Management, Team leadership, Cross-functional coordination
Preferred skills
Experience with EU GMP Annex 11, FDA cGMP, GAMP, SAP/SAC, Office 365, Quality Management Systems
Technologies
SAP/SAC, Office 365, GAMP, EU GMP Annex 11, FDA cGMP
Responsibilities
Lead the Data Governance team and define requirements for site-wide governance; Develop and implement solutions for data integrity and security; Coordinate GAP analyses and drive corrective actions; Support audits, inspections, and regulatory submissions; Train stakeholders on data governance topics; Report on status, risks, and resource needs to leadership.
Seniority
Senior, hands-on IC with team leadership