Global Quality Management Systems Lead

hace 1 semana

Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completo

About the Role

As a Global Quality Management Systems Lead at Novartis Farmacéutica, you 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. You will drive interactions with various functions, including GDD, TRD, Country, GMA, NIBR, and Regulatory Affairs, through a defined governance model.

Key Responsibilities

  • Establish and run the QMS network for GCP, GLP, and GVP areas
  • 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 on QMS-related activities
  • Represent global QMS at various boards/meetings in the GCP, GLP, and GVP areas and ensure feedback from the 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 QMS representative and liaison partner in other initiatives, boards, meetings as necessary
  • 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, all required activities for successful and timely execution are completed, and the roll-out to impacted local entities across Novartis is achieved
  • Establish and maintain a community/network of Subject Matter Experts or Single Points of Contact and drive interactions with corresponding Functions
  • Establish strong partnership with key stakeholders
  • Create synergies and opportunities by leveraging lessons learned and communicating them to the SMEs and stakeholders as applicable
  • Participate in benchmarking activities as applicable and keep up to date with industry standards
  • Maintain knowledge of current industry trends and Health Authority expectations

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
  • Leadership and Project Management skills to ensure successful implementation of projects or initiatives
  • Curiosity and agility to be able to adapt to a fast-moving environment
  • English fluent, written and spoken. Other languages are a plus

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