Dipl.-Ing. Jürgen Waditschatka

I provide interim and permanent leadership that accelerates transformation, stabilizes operations, and delivers lasting value for life science companies. My expertise spans Quality, Manufacturing, CMC, Regulatory Affairs, and Supply Chain. Core services include strategic leadership, interim management, digital transformation, crisis management, regulatory strategy, and organizational development.

Deliver courses on GMP compliance and CMC regulatory strategy (eCTD module 2 and 3 preparation).

Led end-to-end CMC strategy and execution across manufacturing, quality, supply chain, and regulatory operations at multiple sites to meet regulatory milestones and commercial supply goals. Chaired COVID Supply Forum, ensuring 98% on-time delivery under pressure. Drove governance via stakeholder communication, milestone tracking, and reporting. Deputized for Program Director, supporting strategic management activities.

Led qualification, commissioning, and process validation for pharma projects, managing approvals and deviation reports to ensure compliance. Conducted feasibility studies and developed qualification documentation, including change management, risk analyses, test plans, and SOPs. Established and led Austrian Compliance department, overseeing team leadership, resource planning, and people development. Supported business development and CQV excellence initiatives.

Led Quality Systems team at new GMP manufacturing site, ensuring GMP and regulatory compliance through coaching and leadership. Directed successful GMP inspections and audits, confidently representing quality systems to authorities. Implemented KPI tracking, trend analysis, and continuous improvement using Lean, Six Sigma, and MPS. Supported Global Regulatory Affairs with submissions, queries, and regulatory commitments for vaccine manufacturing.

Led CMC strategy and dossier management for biologics and small molecules, enabling EU marketing authorization of pegylated interferon. Developed regulatory submission plans and managed authority queries to ensure compliance and timely approvals. Acted as Subject Matter Expert across global R&D and external partners, driving cross-functional alignment. Spearheaded digital transformation and process improvements to boost efficiency and inspection readiness.

With 17+ years in Quality, Manufacturing, and CMC Strategy, I progressed from operational roles to Global Senior Leader until Baxalta-Shire reorganization. Held key leadership roles managing global multi-site operations, coaching teams, and driving GMP compliance. Led digital transformation, KPI tracking, and regulatory submissions. Spearheaded strategic initiatives on Quality by Design, risk governance, and supplier partnerships, ensuring operational excellence and continuous improvement.

Ensured consistent product quality and compliance by optimizing production data management and coordinating cross-departmental processes. Streamlined administrative workflows and led SAP implementation, resulting in improved operational efficiency and accurate production costing.

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