Ilona Brundiers-Albers

Heading the Product Quality Lead, External Manufacturing, and Device QA group; overseeing quality in both program and product strategy, as well as the external manufacturing network

• Heading the Product Quality Lead, External Manufacturing, and Device QA group; overseeing quality in both program and product strategy, as well as the external manufacturing network

Driving quality strategy and leading quality operations (GMP, GCP and Quality Systems); accountable for achieving the quality goals; ensuring GMP-compliant manufacture and supply of IMP; ensuring GCP-compliant conduct of clinical studies; conducting quality review

End-to-end product quality stewardship of biologics across the entire global network, including CMOs and alliances; responsible for major escalations and investigations, overseeing quality aspects of regulatory submissions, inspection readiness; leading platform-wide quality harmonization projects

Managing all QA aspects of oncology development portfolio across multiple sites, encompassing GLP, GCP and GMP; leading the QA strategy for assigned portfolio; member of the Business Development & Licensing team; ensuring bioanalytical laboratories are prepared for inspections

Overseeing QA across various development projects, ensuring compliance with cGLP, cGMP, and cGCP standards throughout development, and commercialization processes

Created a collaborative interface among CMC, QA, RA, and CMOs; managing both internal and external CMC-related QA and RA activities across all programs; creation of regulatory filing documentation; ensuring the release of clinical trial material; support of quality audits

Heading a QC laboratory with a team of six members; responsible for the release analysis of biotechnological pharmaceuticals; planning, conducting and assessment of stability studies; cooperation with both internal and external partners

Planning, executing, and assessing stability studies of biopharmaceuticals, preparing submission documentation and answers to deficiency letters (Module 3)

Managing documentation in accordance with ISO and GxP standards; maintaining a document repository; served as a member of the Quality Management team; validation of analytical methods; responsible for the Laboratory Information Management System