.Job Description Summary As the primary quality contact for Business Process Owners (BPOs) in Development, you are the guardian of excellence, ensuring seamless quality oversight of clinical processes. Your mission is to uphold the highest standards of compliance with Health Authorities' requirements and internal benchmarks. In this dynamic role, you will forge powerful partnerships within CQA and RDQ, providing strategic and operational QA/GxP expertise. You will be the champion of a quality mindset, driving alignment with the broader goals of RDQ and Development. Your leadership will inspire a culture of excellence, ensuring that every step taken is a stride towards unparalleled quality and success. Job Description ** 2 positions available ** Primary Location: Barcelona or Madrid, Spain Alternate Location(s): London, England / Dublin, Ireland Working model: All locations have a hybrid working model (12 days per month in the office) Note: Novartis is not able to offer relocation support for this role. Please only apply if the location is accessible for you. About this role: As the primary quality contact for Business Process Owners (BPOs) in Development, you will ensure compliance with Health Authorities requirements and internal standards while driving continuous clinical process enhancements. You will lead quality initiatives, manage quality risks, and oversee quality issue management across Development Units and therapeutic areas. By partnering within CQA and RDQ, you will provide strategic QA/GxP expertise, ensuring exceptional quality, proactive compliance, and superior business satisfaction. Key Responsibilities: Actively drive a culture of Quality and successfully embed a Quality mindset across Development by forging strong business partnerships, positively impacting business deliverables, and effectively implementing the strategy, mission, and purpose of RDQ. Act as primary quality contact for Business Process Owners (BPOs) and actively engage with relevant RDQ representatives to provide comprehensive guidance. Collaborate with BPOs to conduct regulatory requirements gap assessments and implement necessary actions to address any identified gaps. Monitor and evaluate changes in regulations, best practices, and internal process working groups, and promptly initiate changes to clinical processes as applicable. Guide Quality System Owners (QSOs) and BPOs in the development of a robust strategy for clinical process changes, considering interdependencies and guide respective risk business owners in all aspects of risk management. Collaborate closely with BPOs to prepare for audits, actively participate, support formulating robust CAPA plan, ensuring its comprehensive review and flawless implementation. Collaborate closely with the Head GCP Inspection Management and GCP Inspection Project Managers when a GCP Health Authority Inspection is announced, promptly identifying potential risk areas that may impact the process