E2E Regulatory Affairs (RA) & Quality Management (QM) Process Expert & Transformation Lead
Core
Driving global standardization, operational excellence, and transformation across the end-to-end Regulatory Affairs (RA) and Quality Management (QM) value chain.
Role type
Senior Process Expert & Transformation Lead
Builds
Harmonized service delivery models, unified process taxonomies, and standardized KPI frameworks for RA and QM functions.
Domain
Life Sciences / Healthcare Regulatory & Quality Management
Required skills
Cross-functional transformation leadership, global process standardization, ERP implementation (SAP S/4HANA), process design methodologies (BPMN, Lean, Six Sigma), stakeholder management, change management, budget management, audit compliance support.
Preferred skills
Lean Six Sigma Green/Black Belt, PMP/PRINCE2, Windchill PLM, experience in Global Business Services (GBS).
Technologies
SAP S/4HANA, Oracle, Windchill
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; support ERP implementations by translating business requirements into optimized process solutions; mentor process analysts and operational teams; facilitate workshops for stakeholder alignment on process changes.
Seniority
Senior, hands-on IC with strategic influence