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**Summary**:
~ Proporcionar garantía de calidad y supervisión de cumplimiento a las funciones de desarrollo e investigación. Impulsar la supervisión de los sistemas e iniciativas de gestión de la calidad dentro de la organización global, regional y nacional, asegurando el cumplimiento de los requisitos reglamentarios de las autoridades sanitarias aplicables (por ejemplo, GCP, GLP, GMP, PV, IP) y los procedimientos y estándares de calidad de Novartis. Modele comportamientos de buena calidad mientras promueve una cultura de calidad (por ejemplo, la primera vez correcta, etc.) para impactar positivamente a las partes interesadas que no son de calidad (por ejemplo, NIBR, GDD). Desarrollar, impulsar y/o apoyar iniciativas de planes de Calidad con el fin de lograr la estrategia, misión y visión organizacional.
**About the Role**:
The RP QA is responsible for assuring qualification activities are planned and managed with an adequate assurance of quality and compliance as it pertains to the maintenance of the regulatory landscape. Radiopharmacies may include Site Radiopharmacies (SRP) and Central Radiopharmacies (CRP) (and intermediate RP). The RP QA will operate in direct collaboration with global and local
Research & Development Quality (RDQ) and G lobal Clinical Operations (GCO) colleagues ( Technical Research and Development (TRD) QA, Study Lead, Study-Start-Up Teams, Clinical Research Associates (CRAs) etc.), to ensure the scope of activities being brought in is clearly communicated and understood by receiving functions and actions taken follow Novartis requirements and relevant Health Authority (HA) regulations and guidance. The RP QA will be teamed up with an RP QA colleague from TRD QA to combine Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) knowledge.
The RP QA is responsible for supporting countries in qualifying and oversighting Radiopharmacies, supporting health authority inspections and audits and leading novel projects (e.g. developing quality risk management strategies, planning and management of resources to support qualification and oversight activities, continuous improvement of the process, establishing a RP TPM oversight system).
**Major Accountabilities**
- ESP/Supplier Management: Responsible for the execution of QA activities required for the qualification/requalification of RPs. Ensure the RP selection, QA agreements and oversight processes are properly followed. Drive Qualification and Oversight of RPs. Support global stakeholders and local teams with the execution of activities required for the qualification/requalification of RPs. Ensure, QA agreements and oversight processes are established and followed to support continuity of activities.
- Risk Identification and Management - Identify any risks relevant to the RP Qualification and Oversight into Novartis and assure that those risks and any mitigation strategies are communicated to internal and external stakeholders. Assure that risk strategies are working as intended and adjust as needed. Plan and coordinate on a risk-based approach audits with the unified quality audit program (UQAP) Audit Group for Central Radiopharmacies or Quality Visits by local CDQ colleagues. Monitor processes and Key Quality Indicators (KQIs) to proactively identify potential quality risk withing the RP Oversight Process. Collaborate with business partners to ensure that risks are reviewed for root cause, impact, and recurrence and assure that relevant line function owners put in place mitigation plans to address. Ensure adequate and timely escalation of issues to relevant functions as needed.
- Audits and Inspections - support audit and inspection readiness and knowledge transfer to local CDQ associates as needed to assure a successful audit and/or inspection. Knowledge transfer can include collating and communicating information on the RP processes, facilitating the development of storyboards in service of explaining processes. May serve as audit/inspection support as needed in collaboration with local QA teams.
- SOPs and Written Processes - Identify/maintain plans for RP Qualification and Oversight SOPs and Guidelines; contribute to plans for deploying SOP training as needed to CDQ teams and other relevant stakeholders. In addition, may be required to review and input on the content of global SOPs that cover RLT Clinical Trial processes on behalf of the CDQ organization.
- Training and communication - Accountable for providing input to and/or developing and executing plans to communicate information and facilitate training for CDQ teams and other stakeholders, including SOPs and written processes, timelines, expectations for local teams, product information, and disease area as applicable. Assure that relevant business areas are maintaining inspection-ready documentation to support reviews of training compliance.
- Continuous Improvement: Utilize lessons learned from audits, inspections, KQI reviews and day-to-day oversight of quali
