RJ Doornbos Bristol Myers Squibb
RJ Doornbos Bristol Myers Squibb
RJ Doornbos, Head of Global Quality Systems, and key member of the Global Quality Leadership (GQLT) team ensuring an effective Quality System is in place for R&D and GPS organizations. The Quality Systems organization supports site operations in GPS, as well as functions performing GxP regulated activities in R&D. Including establishing and maintaining an integrated GxP Quality System Framework to assure that GxP research and development activities and biopharmaceutical manufacturing activities are conducted in accordance with Company requirements, worldwide health authority regulations, and evolving regulatory expectations. To ensure global quality system for BMS is designed and maintained according with evolving regulatory expectations, the quality systems department will contain centers of excellence (CoEs) for key systems such as devices, Change Management, Investigations, Complaints and Systems Ownership. The Head of Global Quality Systems oversees systematic implementation of programs to assure compliance with all principles of current Good Laboratory Practices, Good Clinical Practices, Good Pharmacovigilance Practices, and Good Manufacturing Practices to ensure patient safety and highest standards of quality. Her experience spans the entire product lifecycle in both Quality Operations (R&D and Commercial) and in designing and implementing small- and large-scale Quality Systems including successful execution of US FDA Consent Decree.