Country QA Head, EWA at Novartis International AG

Job Description

• 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.