Austria
Member of the Dental Business Operating Committee (BOC), the senior cross-functional leadership board responsible for defining and executing strategic and operational priorities for the global Dental business.
- Lead the Global Quality organization for Dental Solutions, with direct responsibility for ~400 FTE worldwide and total business coverage of $1.3B in revenue, ensuring compliance with ISO 13485, MDSAP, MDR, and 21 CFR Parts 800 and cGMP. - Drive Operational Excellence: Implement efficient CAPA improvements, root cause analysis, and quality planning to enhance product consistency and compliance. - Strengthen Supply Chain & Quality Culture: Optimize supplier qualification, change management, and cross-functional collaboration to improve reliability and customer outcomes. - Act as Person Responsible for Regulatory Compliance (PRRC) for Dental Solutions, ensuring adherence to EU MDR and related regulatory obligations. - Act as Qualified Person, QP (Art 49 2001/83/EC), for our pharmaceutical manufacturing network - Support business growth and transformation initiatives through M&A quality due diligence and post-deal integration of new entities and partners into the global Quality Management System (QMS), ensuring compliant and risk-based harmonization. - Member of the Dental Business Operating Committee (BOC), the senior cross-functional leadership board overseeing strategic and operational priorities for the Dental business.
• Knowledge Sharing and Discussions: on QC-specific topics, and update on projects such as ISPE Guides, articles, and training. • Collaboration and Best Practices providing a forum for ISPE members to share best practices, breakthrough ideas, and innovations in the QC field. • Regulatory Input and Advancements to focus on specialized topics and provide input to new regulations related to the application of QC in the pharmaceutical industry.
• Global Head of Quality Control for the Thermo Fisher PSG network • Led global Quality Control and Analytical Development across 30 international sites, with direct responsibility for 3000 FTE worldwide. • Member of the Quality Leadership Team (QLT) for Thermo Fisher PSG • Directing cGMP and QC initiatives for industry-leading standards and compliance. • Leading performance and profitability transformation across PSG sites using Lean Labs, PPI, and continuous improvement. • Supported network expansion through M&A quality due diligence and post-acquisition integration of sites into global QC standards, systems, and governance frameworks. • Partnering on testing approaches; establishing of global QC policies/SOPs; acting as global QC subject matter expert.
- Global head of quality control for the Aenova Group - Led Quality Control operations across 16 international sites, with direct responsibility for 600 FTE employed in QC - Supported business growth and site integrations through M&A quality due diligence and post-acquisition harmonization of QC processes, systems, and standards across the global network. - Main driver for QC projects in GMP/cGMP compliance, process harmonization through global policies and operational excellence (e.g. LIMS, Lean Six Sigma projects)
- Representation of the company as qualified person accordingt to §15 AMG - Release of and certification of batches according to GMP Annex 16 - Assurance of GMP-Compliant production and analysis according to AMG - Support and direction in quality improvement projects (e.g. Lean Six Sigma)
- Responsible for on-time FDA/GMP-compliant analysis and qualifications - Handling of OOS, deviations, changes, transfers and complaints - Project lead for the QC-Lean Six Sigma implementation - Daily business conducted through Shape-Lims®, SAP®, Trackwise® and Microsoft Office®.