About this role
Job title: Quality Assurance / Compliance Lead
Role Purpose Provide quality assurance and compliance oversight to development and research functions. Drive the oversight of quality management systems and initiatives within the global, regional, and country organization, ensuring compliance with applicable health authority regulatory requirements (e.g., GCP, GLP, GMP, PV, IP) and Novartis procedures and quality standards. Role model good quality behaviors while promoting a culture of quality (e.g., right first time, etc.) to positively impact the non-quality stakeholders (e.g., NIBR, GDD). Develop, drive and/or support Quality plan initiatives in order to achieve organizational strategy, mission and vision.
About the Role
Major Accountabilities:Provide QA expertise and guidance to ensure compliance with requirement of the quality system are met, including implementation of quality risk-based and GxP relevant process.Lead and manage a QA organization and/or quality project team and collaborate with business partners and other quality groups to ensure health authority and regulatory requirements are fully metTranslate functional QA strategy into applicable operational/compliance activities and support a risk -based implementation and execution of processes.Ensure quality and compliance gaps are addressed and executed for sustainability and implement strategic process improvement, including review of procedural updates, training, process im