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Global Quality Management Systems Director
hace 2 meses
We are seeking a highly experienced and skilled Global Quality Management Systems Director to join our team at Novartis Farmacéutica. The successful candidate will be responsible for establishing and running the Quality Management Systems (QMS) network for Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and Good Vigilance Practices (GVP) areas.
Key Responsibilities- Establish and maintain the QMS network for GCP, GLP, and GVP areas, ensuring compliance with regulatory requirements and industry standards.
- Drive interactions with Global Development, Clinical Development, and Regulatory Affairs Functions through a defined governance model.
- Align with other Business functions within the GCP, GLP, and GVP areas on QMS-related activities.
- Represent global QMS at various boards and meetings in the GCP, GLP, and GVP areas, ensuring feedback from the network is taken into account in global initiatives or projects.
- Function as the key point of contact for Global Development, Clinical Development, and Regulatory Affairs 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.
- Author and review respective QMS documentation.
- Lead and/or participate in key QMS projects or initiatives, ensuring that defined quality elements and compliance requirements are addressed.
- 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.
- Leadership and Project Management skills to ensure successful implementation of projects or initiatives.
- Curiosity and agility to adapt to a fast-moving environment.
- English fluent, written and spoken. Other languages are a plus.
Novartis is a global healthcare company that is committed to discovering, developing, and delivering innovative medicines to patients around the world. We are dedicated to improving people's lives and are passionate about making a difference in the world.
