The Head of Quality will work cross-functionally with Regulatory, Clinical Operations, Clinical Development, Pharmacovigilance, and Technical Operations as well as external CROs, clinical sites, CMO/CDMOs, and PV partners, to ensure compliance with applicable global regulations and to maintain a strong culture of quality, integrity, patient safety, and data integrity. Ensure effective oversight and timely resolution of clinical quality issues, deviations, investigations, CAPAs, change controls, and product complaints, including protocol deviations, informed consent issues, and site-level findings, seeking input from relevant departments to ensure fully informed evaluations of quality impact.