Summary

Location: Schaftenau, Austria

Role Purpose:
Provide quality assurance expertise, guidance and support to operational activities in development and research organizations to ensure compliance with applicable regulatory requirements and Novartis procedures and quality standards. Manage projects, including Quality Plan initiatives, and processes that support quality objectives to assure their compliance with GxP regulations.

About the Role

Major accountabilities:

• Support maintenance of the regulatory-required files for health authority inspections and assist with health authority inspection management -Support generation of Quality Plans (and review other plans for quality/safety aspects) for clinical programs -Support initiatives to maintain or improve quality performance and compliance of operational activities including risk management, health authority reporting, IT systems -Support initiatives focused on quality, process and compliance improvement, including identification of opportunities and develop strategies aimed at improving quality while ensuring compliance with regulatory requirements -Ensure information gained during quality and compliance initiatives, as well as audit and assessment results, are evaluated to identify any regulatory, compliance and QA training needs -Aid in the identification of quality issues and assist with root cause investigations and Support the development of corrective and preventative action plans (CAPA), including monitoring status to Ensure issues are addressed, completed and documented.
• Provide assistance in the remediation of deviations, Ensure follow up and monitoring of associated corrective and preventive actions.
• Manage and Support quality aspects of projects and activities, including those related to third parties, analytical instruments, manufacturing equipment, quality plans, training, IT validations, etc. -Review and approve quality deliverables to ensure compliance (including procedures, records, third party work, contractors, clinical trial material, components, gap assessments ) -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

• Clusters Quality System in place and continuously updated, as requiredrisks proactively identified and effectively mitigated -The number and severity issues identified during internal and external audits.
• Demonstrated/recognized leader of specific GxP; early external/industry engagement -Sufficient financial knowledge (e.g., cost management, budget forecast, etc.) -Role Model of Novartis culture, values and behaviors

• Functional Breadth.
• Critical Negotiations.
• Project Management.
• Collaborating across boundaries.

• English