Dipl.-Ing. Jürgen Waditschatka

Quality-CMC Solutions: Bridging Gaps – Accelerating Impact - Tansform GxP-Compliance von einer Kostenstelle in einen agilen Wertschöpfungsmotor. Strategische Weitsicht trifft Shop-Floor-Pragmatismus "Quality as a Strategic Engine" Portfolio: # CMC & Launch Excellence: R&D-to-Commercial, eCTD Submission Strategie FDA/EMA # Digitale GxP Transformation (Industry 5.0): GxP-Workflows & Dashboards # Regulatory Architecture & Krisenmanagement # Change & Quality Ownership Selected References: BioNTech & Takeda

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

Led cross-site CMC strategy and execution across R&D, manufacturing, quality, supply, and regulatory functions. Chaired COVID Supply Forum (rebuild on-time delivery supply and release). Deputized for Program Director and engaged in strategic management and stakeholder communication.

* Established the Austrian Compliance department and led enterprise-wide commissioning, qualification, validation (CQV) excellence initiatives. * Orchestrated feasibility studies and the execution of major Pharma projects: Held end-to-end responsibility for the full CQV spectrum, including risk, change control, and GxP-Compliance Management.

Led regulatory and quality strategies for medical software: Orchestrated the CE submission roadmap and ensured end-to-end pre-market compliance, including comprehensive risk management and audit facilitation to guarantee conformity throughout the entire development lifecycle.

* Led Quality System rollout for a new manufacturing site; Spearheaded the document and data management architecture and implemented KPI tracking via Lean Six Sigma (Merck Production System). * Acted as the primary interface for Global Regulatory Affairs regarding submissions and variations, ensuring seamless alignment between site operations and regulatory requirements.

CMC Strategy & eCTD Management: Led centralized EMA marketing authorization for a recombinant pegylated interferon & managed renewals/variations for solid dosage forms, accelerating LoQ resolution. Strategic Stakeholder Management: Steered global filing strategies and authority liaisons to ensure compliance and fast-track product approvals. Digital Transformation & Process Architecture: Enhanced CMC development efficiency and ensured permanent inspection readiness through optimized, digital workflows.

Key roles: Global Head of Hemophilia Quality Product Owners, Global Quality Product Owner, Quality CMC Expert, Head of Buffer/Media Preparation, Head of Antigen Purification, and Manufacturing PM. Directed strategic initiatives for digital quality transformations and process optimization across Tech-Ops, QC, and QbD. Managed complex CAPAs and led teams through multiple successful FDA/EMA marketing authorizations and inspections over 17 years.

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