E2E Regulatory Affairs (RA) & Quality Management (QM) Process Expert & Transformation Lead
Core
Drive global standardization, operational excellence, and transformation across the end-to-end Regulatory Affairs (RA) and Quality Management (QM) value chain, serving as the primary regional/global authority supporting the Global Process Owner.
Role type
Senior IC process expert and transformation lead (Regulatory & Quality)
Builds
Harmonized service delivery models, unified process taxonomies, and standardized KPI frameworks for global RA/QM operations
Domain
Life Sciences / Healthcare / Regulatory Affairs / Quality Management
Required skills
Process design and harmonization, Global process governance, Cross-functional transformation leadership, ERP implementation (SAP S/4HANA), Stakeholder management and influence, Change management, KPI monitoring and analysis, Documentation control, Budget management, Workshop facilitation
Preferred skills
Lean Six Sigma Green/Black Belt, PMP or PRINCE2 certification, Windchill PLM experience, Shared Services/GBS background, Advanced English and other languages
Technologies
SAP S/4HANA, Oracle, Windchill, BPMN, Lean, Six Sigma
Responsibilities
Lead design and implementation of E2E RA & QM processes; Drive global standardization and deployment of unified process taxonomy; Identify process bottlenecks and implement corrective actions; Collaborate with Global Process Owner to define future-state processes; Act as single point of contact for Demand Management; Support ERP implementations by translating business requirements into optimized solutions; Facilitate workshops to ensure stakeholder alignment; Mentor process analysts and operational teams.
Seniority
Senior, hands-on IC with strategic influence
