Rene Lepczynski

• Own the BPMS and QMS architecture across 8 sites, harmonizing standards like Job Change, 5S, TPM • Lead cross-site OpEx and Quality teams with final decision authority on process design • Built Power BI analytics, structured monthly Plant Performance Reviews • Lead QMS integration of newly acquired plants across Italy, France, Germany • Structured the Group's Safety Organization, driving a culture shift toward fewer incidents • Quality representative in the global ERP migration team

• Standardized quality management across manufacturing sites in Europe, the US, and Asia • Recognized with the Gerresheimer Executive Innovation Award • Harmonized end-to-end processes across IT, Controlling, Operations, Sales, and Supply Chain Management • Global Process Owner for eQMS platforms (CAPA, Deviation, Change Control, Batch Release) • Led the SAP QM CAPA system rollout • Replaced static reporting with automated Power BI-based performance and risk analytics

• Responsible for GMP-compliant batch release, clean track record in regulatory inspections • Managed deviations, complaints, and CAPA processes end-to-end • Reduced recurring non-conformities and Cost of Non-Quality (CNQ) • Conducted internal and supplier audits per ISO 9001 and ISO 15378 • Designed KPI reporting structures, later foundation for global digitalization • Reduced blocked-stock rates via MES-driven defect detection (Safepack initiative)

• Supported MES rollout through master data setup • Developed standardized quality and inspection plans in SAP QM • Drove digital transformation of the quality department • Automated reporting, replacing paper-based documentation • Gained hands-on experience under ISO 15378 and GMP guidelines

Maschinen- und Automatisierungssysteme