Global Quality Management Systems (QMS) Manager

Global Quality Management Systems (QMS) Manager

Spain

Summary

About the Role

Key responsibilities:

1. 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.
2. Align with other Business functions within the GCP, GLP, and GVP areas e.g. Clinical Development and acquired companies, on QMS related activities.
3. Represent global QMS at various boards/meetings in the GCP, GLP, and GVP areas and ensure the feedback from the network is considered in global initiatives or projects.
4. Function as the key point of contact for GDD, TRD, PV, GMA, NIBR associates on all topics requiring global QMS involvement, as well as act as a QMS representative and liaison partner in other initiatives, boards, meetings as necessary.
5. 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.
6. Author/review respective QMS documentation.
7. Lead and/or participate in key QMS projects or initiatives.
8. Establish and maintain a community/network of Subject Matter Experts or Single Points of Contact and drive interactions with corresponding Functions.

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 a focus on QA processes and underlying regulatory requirements and industry standards/best practices.
• 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.

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