Dipl.-Ing. Jürgen Waditschatka

Interim Leadership in Quality (QMS, QA, CQV), CMC RA, Manufacturing, and Analytics; Ensuring business continuity, agile execution, stakeholder confidence, and risk mitigation during transformation or crises; Empowerment of teams and future-ready structures; Cross-Functional Program and Project Leadership; Operational Excellence and Compliance; Development and streamlining of integrated GxP, ICH, and ISO-compliant systems; Inspection Readiness; Drive GxP deliverables; CMC Regulatory Submission Management

GxP compliance, CMC regulatory product strategy and submission dossier documentation

Provided strategic and operational leadership to the Quality Assurance team during a critical transformation phase.

End-to-end project management within Takeda’s Global Manufacturing & Supply (GMS) organization during a strategic divestment program. Focus on managing critical product, material, and process changes across multiple international manufacturing sites.

Led the implementation of the CMC development and product strategy for the COVID-19 vaccine – from late-stage development through manufacturing, licensing, and launch. Provided expert consultancy across development, engineering, manufacturing, supply chain, quality, GxP compliance, and regulatory affairs.

Led the implementation of the CMC development and product strategy for the COVID-19 vaccine – from late-stage development through manufacturing, licensing, and launch. Provided expert consultancy across development, engineering, manufacturing, supply chain, quality, GxP compliance, and regulatory affairs.

Led Quality, GxP compliance, equipment commissioning, qualification, and process validation (CQV) across multiple client projects. Acted as a senior expert and core team member in shaping the BakerHicks CQV Operational Excellence Program.

Led the implementation and site-specific adaptation of the global Quality Management System (QMS) for a newly established GMP manufacturing site, including leadership of the local QA systems team. Directed strategic CQV-related issue resolution and process optimization to ensure inspection readiness, regulatory compliance and operational excellence.

Led CMC strategy and contract manufacturer (CMO) performance management to drive product development and commercialization in alignment with regulatory requirements. Managed the preparation of high-quality CMC core dossiers, including the successful initial EU marketing authorization of a recombinant pegylated interferon and driving multiple dossier optimizations in the context of variation filings for small molecule products.

End-to-end quality responsibility for all licensed hemophilia products.

Quality leadership for assigned auxiliary, hemophilia, and critical care drugs.

Subject matter expert for dossier compilation, regulatory process steering, and critical multi-site CAPAs.

Operational leadership in aseptic production and supply.

Technical and organizational lead for antigen production processes.

Led GMP implementation, tech-transfer, process and technology optimization.

Bioengineering, specialization on quality management and process optimization

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