Ilona Brundiers

End-to-end product quality stewardship of biologics across the global network, including CMOs and alliances: Quality Lead for escalations and major investigations, quality oversight for regulatory filings, Inspection readiness; leading platform-wide quality harmonization projects

Managing all QA aspects of oncology development portfolio across multiple sites, covering GLP, GCP and GMP; driving the QA strategy for assigned portfolio; BD&L team member; responsible for inspection readiness of bioanalytical laboratories

QA Management across multiple development projects, ensuring that product design, development, and commercialization processes comply with cGLP, cGMP and cGCP requirements

Management of internal and external (CMOs and CROs) CMC related QA and RA activities of all programs; creation of regulatory filing documentation; support of quality audits

Leading a QC laboratory with 6 team members; release analysis of biotechnological pharmaceuticals; planning, conducting and evaluating stability studies; cooperation with internal and external partners

Planning, conducting and evaluating biopharmaceutical stability studies

Managing QC lab with 15 team members, QC of incoming goods and products, equipment qualification, complaint management

Documentation according to ISO and GxP standards, maintaining document repository, member of the QM team, validation of analytical methods, LIMS management