Berlin, Berlin, Germany
As a highly experienced Quality Assurance professional with over 18 years in GxP-regulated environments, I specialise in driving robust Quality Management Systems, managing deviations and CAPAs, and ensuring regulatory compliance across clinical, pharmaceutical, and biotechnology sectors. I've implemented ISO 13485 in several companies, bringing them into compliance as they bring novel products to market. I have a proven track record supporting global organisations through complex QMS transformations, including migrating from paper-based to electronic systems. I aim to balance compliance and operational efficiency, even during challenging transitional periods. Currently, I am the Quality Manager for StratifAI, an exciting startup at the forefront of the interface between AI and oncology, striving to improve therapeutic outcomes in breast cancer care. From 2023-2025, I led quality and compliance for a clinical consulting laboratory service in Spain, overseeing audit readiness, deviation management, SOP authoring, and cross-functional training, bringing the Spain side of the business online and getting our world-class team of technicians up and running. My expertise spans EU GMP standards, ISO 15189, GCP, GLP, and CAP requirements, with a strong focus on developing sustainable quality frameworks and enabling teams to adapt quickly to new systems with minimal disruption. Previously, as Head of Quality at Nuritas, I played a key role in securing FDA GRAS approval and supporting multi-million-dollar funding rounds by delivering rigorous quality and regulatory support. I also managed audits of contract manufacturers and labs to facilitate commercial-scale product launches, demonstrating my capability to align quality with business growth objectives. I am passionate about fostering collaborative relationships, meticulous attention to detail, and building inspection-ready quality environments that drive continuous improvement. I thrive on delivering immediate value to organisations seeking strategic quality leadership and pragmatic problem-solving in regulated settings.
As Quality Manager at StratifAI, I drive the strategic development of our Quality Management System to achieve ISO 13485 certification and CE marking of our breakthrough diagnostic technology prior to market launch. Our first device assesses metastatic risk in early breast cancer directly from digitised histology slides, supporting more precise adjuvant treatment decisions. Validated on more than 6,000 patients, the platform is already advancing research while progressing through EU and US regulatory pathways. In this role, I lead quality and regulatory strategy, champion a culture of compliance and continuous improvement, and ensure the organisation is equipped with the systems, training, and processes needed to deliver safe, effective, and compliant medical technologies to market.
My role as QA Manager for Laboratory Services EU at CTI, allowed me to lead quality assurance across our European laboratories, ensuring compliance with GCP, ISO, and international regulatory standards. I drove the development and oversight of the QMS to support high-quality clinical trial and laboratory services. My role focused on QA leadership in audits, regulatory inspections, vendor qualification, and data integrity, while fostering a strong culture of compliance and continuous improvement. By partnering with cross-functional teams, I helped ensure that laboratory operations consistently delivered reliable results that advance oncology and rare disease research worldwide as the European Union site in Spain became operational.
During my time as Head of Quality at Nuritas, I led the global quality strategy, ensuring our pioneering peptide discovery platform and products met the highest standards of safety, compliance, and customer trust. I oversaw the development and execution of our Quality Management System, embedding best practices across R&D, manufacturing, and commercial operations; and I supervised the first commercially-manufactured batch of PeptiStrong. In this role, I partnered directly with senior leadership to align quality with business objectives, drive regulatory readiness, and build a culture of continuous improvement. My responsibilities spanned regulatory compliance, supplier quality, audits, training, and quality risk management ensuring that every stage of our pipeline supported scientific excellence and successful market delivery. By leading quality at Nuritas, I helped bring breakthrough, AI-driven peptide solutions to market with the reliability and rigour required to transform health outcomes worldwide; and contributed to progressing business transition from a startup to a market leader.