Novartis is a global healthcare company based in Switzerland that provides solutions to the evolving needs of patients worldwide.
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Responsible to ensure compliance and further development, support, maintenance & constant review of the Quality Systems and support for projects as well as the reporting of the necessary performance indicators (KPIs) & quality indicators (KQIs).
Support implementation of effective and efficient processes that fulfill regulatory requirements & expectations in a sustainable way for the global Novartis portfolio of products.
Ensure that the Quality Systems are compliant with the global guidelines and that all relevant regulations and legal requirements are adhered to set up a Quality System with GxP and monitor the periodic inspection and updating quality-relevant processes
Continually improve & harmonize the quality-relevant processes, strengthen the awareness of quality, technical service, quality-relevant product tests, eliminate barriers relevant to the process and anticipate quality problems.
Support the departments in case of Quality assurance questions
Support regulatory risk management through identification, assessment, mitigation and communication of any potential regulatory /compliance risks
Performs self-assessments
Support a compliance & quality culture
Provides expert advice and input and harmonize and continuous optimize processes within QA area
Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
Distribution of marketing samples (where applicable)
Minimum Requirements
People Leadership
Operations Management and Execution Project Management
Financial Management
Functional Breadth
Fix-its/Turnarounds English
Risk Management
Quality decision making
Knowledge of compliance requirement for all internal and external regulations
Knowledge of TQM and related industry GxP standards and processes
Quality Standards.
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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