Sascha Holzmann

Leading a team of Quality Managers in Argentina, Germany, and the US, servicing PAREXEL’s Clinical Trial Supply & Logistics Organization • Reorganized a team of 5 Quality Managers in Argentina, Germany, and the USA • Improved the Problem Record & CAPA processing time • Increased the overall efficiency by implementing Problem-Solving (DMAIC, PDCA, Ishikawa) and 5S methodologies • Orchestrated the global Quality Management System enhancement • Streamlined the Global Supplier Relationship Management

• Built and led a team of 10 Associates in Germany, Russia, Singapore, and Japan • Instituted a global, integrated Quality Management System • Increased the overall efficiency of Quality Control activities via multiple process improvements • Created enhancements to the Inventory & Supply Chain Management System by employing the Scaled Agile Framework (SAFe) and quarterly development cycles

Leading the APAC and EMEA Quality control operations in PAREXEL depots, a team of Responsible Pharmacists, Heads of Quality Control and Quality Specialists in Germany, Russia, Singapore, and Japan.

• Established and led a team of 4 Associates in Germany and the UK • Launched 3 global project roll-outs of training activities across business units and departments, trained 2000 colleagues on a new system for Revenue Management • Improved the process efficiency using Microsoft SharePoint for Planning, Forecasting, and Documentation of Training Activities across the enterprise

Global head of the Business & Process Operations group as part of the Portfolio & Project Leadership organization. Leading a team of 16 Specialists, Coordinators and Managers in India, Germany, Argentina, and the USA.

Head of the EMEA Clinical Trial Supply Operations, leading the Germany based group (Assistants, Specialists, Clinical Logistics Leaders and 4 Managers, 50 FTE + temp staff). Strategic support and consultancy for clients, strategic, and operational teams in projects / partnerships. • Strategic planning and execution of enhanced Clinical Logistics Services offering • Established accounts, defined operational roles & responsibilities and processes for strategic alliances with major pharmaceutical companies

• Led a team of 15 Logistics Project Management Associates in Germany • Accomplished a global yearly staff growth of ~30% by targeted training, mentoring, and coaching approaches • Spearheaded 5 strategic partnerships and clinical development programs as subject matter expert and implemented tailored Supply Chain Management strategies • Shaped strategies for sourcing, manufacturing, and distribution of pharmaceutical products • Introduced new SOPs and Unit Policies to the Quality Management System

• Responsible for several phase II and III studies with main therapeutic areas Vaccination, Transplantation and Growth Hormone Deficiency with focus on CRF Design, Database Design, Discrepancy Management and SAE Reconciliation, Medical Coding • Supervised junior staff / trainees and acted as mentor

Validation of a Clinical Data Management System according to GAMP and 21 CFR Part 11 requirements. • Development of Module Design Specifications • Development of Test Plans for Operational and Performance Qualification • Executing Operational and Performance Qualification tests • Maintenance and filing / archiving of documentation • Setup and maintenance of Hardware for Test-Environment

Clinical Research in general, basic knowledge on Monitoring, Data Management, Statistics, Protocol writing, Medical, Safety Reporting