(HD299) - Global Quality Management Systems (QMS) Manager - Barcelona
Summary: Responsable de garantizar el cumplimiento y el desarrollo, soporte, mantenimiento y revisión constante de los Sistemas de Calidad y soporte para proyectos, así como la presentación de informes de los indicadores de rendimiento (KPI) e indicadores de calidad (KQI) necesarios. Apoyar la implementación de procesos efectivos y eficientes que cumplan con los requisitos y expectativas reglamentarios de manera sostenible para la cartera global de productos de Novartis.
About the Role:
Key responsibilities:
Establish and run the QMS network for GCP (Good Clinical Practices), GLP (Good Laboratory Practices) and GVP (Good Vigilance Practices) areas and drive interactions with GDD, TRD, Country, GMA, NIBR, and Regulatory Affairs Functions through the defined governance model.
Align with other Business functions within the GCP, GLP and GVP areas e.g. Clinical Development and acquired companies, on QMS related activities.
Represent global QMS at various boards/meetings in the GCP, GLP and GVP areas and ensure the feedback from his/her network is taken into account in global initiatives or projects.
Function as the key point of contact for GDD, TRD, PV, GMA, NIBR associates on all topics requiring global QMS involvement.
Act as a subject matter expert for selected Quality processes and collaborate with the respective QSO/Process owner to ensure GxP compliance of the processes and tools within own remit.
Act as Process Owner for designated processes to drive process lifecycle management from development to archiving of related IT systems, such as GxP Regulatory Assessment process.
Author/review respective QMS documentation.
Lead and/or participate in key QMS projects or initiatives ensuring that defined quality elements and compliance requirements are addressed.
Establish and maintain community/network of Subject Matter Experts or Single Points of Contact and drive interactions with corresponding Functions.
Create synergies and opportunities by leveraging lessons learned and communicating them to the SMEs and stakeholders as applicable.
Participate in benchmarking activities and keep up to date with industry standards.
Maintain knowledge of current industry trends and Health Authority expectations.
Obligatory requirements:
Education: University degree in Pharmacy, Chemistry, Engineering or equivalent related discipline preferably in Quality Systems.
6+ years' experience in Pharmaceutical, Chemical or Biological Operations with focus on QA processes and underlying regulatory requirements and industry standards/best practices.
Specific practical experience and expertise in both Clinical Operations and Regulatory Affairs.
Good understanding of Novartis QMS principles.
Senior expert level understanding of GxP regulations and guidelines, and solid understanding of health authority expectations and industry trends.
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