Country quality head – São Paulo/SP

SP | São Paulo
Efetivo (CLT)
Biólogo
Biomédico
Bioquímico
Biotecnologista
Farmacêutico
Químico

Main responsabilities

• Ensure safe and compliant products for patients (market & clinical) while supporting business priorities Support adoption of quality principles, policies and guidelines Represent the face of Novartis to HA Manage reputation and quality risks
• Lead Cross Divisional QA Board, brings up issues Harmonize and simplify QA practices/processes across divisions and implement a consistent standard across the organization Increase operational efficiency and agility.
• Build practical quality based relationships with the business partners External orientation for benchmark perspective Continuous people and talent management
• Quality oversight of GxP site functions . Acts as site Technical Responsible Person (Qualified Person).Ensure regulatory compliance and implementation of corporate quality standards and regulations status of local HA registration
• Drive standardization and efficiency gains through innovation and operational excellence projects, aligned with Region Americas strategy
• Lead the development of Quality Culture with high awareness on data integrity and close collaboration business partners, and ensure a state of the art Country Quality Organization is in place to best support overall business strategy.

Role requirements

• University degree in the pharmaceutical/life science field such as but not limited to a pharmacist, biochemist, microbiologist or other specialized biologist, biotechnologist or chemist
• Multiple years ( 10+ years) of relevant thought experience in the pharmaceutical industry (Quality, Manufacturing or Development), with strong experience (several years) in the Quality area (GxP-Compliance, Quality Assurance and/or Control)
• Knowledge in and experience with major international pharmaceutical regulations (US FDA, EMA, ICH, WHO, etc.) and with the related Health Authorities (e.g. US FDA, EMA, PMDA, TGA, Anvisa, etc.).
• People Leadership Operations Management and Execution Project Management
• Financial Management
• Business Exposure
• Strong analytical thinking
• Expertise Laboratory equipment Quality Control (QC) Testing Product Release Art Curator Knowledge of GMP Management of Quality Audit
• Business fluent in English (verbal and in writing), ideally advanced skills in a second internationally frequently used language