Nina Bjork

Senior Consultant, GxPAssure

Nina Bjork is a seasoned quality and compliance executive and consultant with more than 20 years of experience across the regulated products sector, including biotechnology, pharmaceuticals, advanced therapy medicinal products (ATMPs), and medical devices. She partners with organisations to design, implement, and remediate phase-appropriate Quality Management Systems (QMS), strengthen inspection readiness, and enable successful growth from early development through clinical and commercial operations.

Her expertise includes building and remediating quality systems, leading inspection readiness programmes (including pre-approval and mock inspections), and guiding organisations through scale-up, clinical-to-commercial transitions, and complex multi-site operational alignment across Manufacturing, Quality, Supply Chain, and Production. Nina is known for pragmatic problem-solving, organisational development, and clear, effective communication—bringing strong leadership to align operational execution with strategic objectives and maximise value.

Throughout her career, Nina has held pivotal global and site-level Quality leadership roles, supporting organisations across development phases and in both clinical and commercial manufacturing environments. She has extensive experience collaborating with global Health Authorities and has served as a Qualified Person (QP), overseeing both outsourced and on-site activities spanning supply chain operations, process development, validation, engineering, and manufacturing.

With senior operational and corporate-level experience in Quality and strategic programmes, Nina is passionate about helping organisations identify and remove barriers to sustainable growth, strengthen compliance foundations, and build long-term operational stability.

Nina is a native Icelandic speaker with professional working proficiency in English, and limited working proficiency in Danish, Swedish, and Norwegian.