Dipl.-Ing. Jürgen Waditschatka

Architect for Operational Clarity & Navigator for Smart Transformation: Designing tailored operational engines for highly regulated value chains to evolve traditional structures beyond their limits, safeguard product quality, & strengthen business resilience. Core Focus: Matrix & Line Leadership | Executive Sparring & Sounding Board | OpsEx | Full Life-Cycle Navigation (Dev to Supply) | Product- & Network-Governance | Authority Confidence | eQMS & IMS Architecture | Digital GXP Evolution (Industry 5.0).

GMP Compliance, Regulatory Submission Strategy (MAA - CTD Module 2 and 3), and CMC Project Management.

Directed cross-site CMC strategy and operationalization across R&D, Manufacturing, QC, Supply, and RA. Chaired the COVID Supply Forum, guaranteeing 98% On-Time-Delivery (OTD) through high-velocity product release cycles. Acted as Deputy Program Director, spearheaded strategic communication with key stakeholders and authorities.

Architected and scaled the Austrian Compliance department from the ground up. Directed high-stakes CQV projects and optimized companywide stage-gate processes to ensure technical and CQV excellence in large-scale engineering (Commissioning, Qualification, Validation).

Orchestrated regulatory submissions and ensured end-to-end pre-market compliance and risk management for medical software assets.

Spearheaded the tailored QMS architecture and implementation, including data & document sovereignty frameworks. Implemented advanced KPI tracking via Lean Six Sigma methodologies. Acted as primary interface for Global RA to ensure operational alignment to submission requirements.

Directed CMC compliance and eCTD submission strategies: Successfully led the centralized EMA marketing authorization for a recombinant pegylated interferon (BESREMi). Architected Global Product Lifecycle Management (PLCM) frameworks and digital-enhanced governance models for multi-asset portfolios, ensuring seamless renewals and variations across international markets, significantly accelerating product approvals and LoQ resolution.

Evolution from Operational Expert to Global Senior Leader: Global Head of Hemophilia Quality Product Owners (QPOs), Global QPO for multiple products (Hemophilia, Critical Care, Excipients), CMC-RA Expert, Manufacturing Lead (Media Preparation, Antigen Purification), and MS&T Project Manager. Key Impact: Product Quality & Launch Management; Operational Excellence & Stabilization; Inspection & Compliance Management; Strategic Quality Governance; Life-Cycle- & Network-Management (In-house / CMO).

Led SAP implementation and optimized production data management to improve operational efficiency and costing accuracy; streamlined workflows to ensure consistent product quality.

Diploma thesis: Regulatory Process Management and CMC Dossier Content Standards for EU Marketing Authorization Applications and Lifecycle Management.

Food technology and meat processing, graduated as engineer - university entrance level