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Global Quality Management Systems Lead

hace 2 meses

Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completo
Job Summary

We are seeking a highly experienced and skilled Global Quality Management Systems Lead to join our team at Novartis Farmacéutica. As a key member of our organization, 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.

Key Responsibilities
  • QMS Network Establishment and Governance
    • Establish and maintain the QMS network for GCP, GLP, and GVP areas.
    • Develop and implement a governance model to drive interactions with GDD, TRD, Country, GMA, NIBR, and Regulatory Affairs Functions.
  • Alignment and Representation
    • 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.
  • Key Point of Contact and Liaison
    • Act as the key point of contact for GDD, TRD, PV, GMA, NIBR associates on all topics requiring global QMS involvement.
    • Represent QMS and serve as a liaison partner in other initiatives, boards, and meetings as necessary.
  • Subject Matter Expertise and Process Ownership
    • Act as a subject matter expert for selected Quality processes.
    • Collaborate with the respective QSO/Process owner to ensure GxP compliance of processes and tools within own remit.
    • Act as Process Owner for designated processes to drive process lifecycle management.
  • Documentation and Project Leadership
    • Author and review respective QMS documentation.
    • Lead and/or participate in key QMS projects or initiatives.
  • Community and Stakeholder Management
    • Establish and maintain a community/network of Subject Matter Experts or Single Points of Contact.
    • Drive interactions with corresponding Functions.
  • Partnership and Synergies
    • Establish strong partnerships with key stakeholders.
    • Create synergies and opportunities by leveraging lessons learned and communicating them to the SMEs and stakeholders.
  • Industry Trends and Knowledge
    • Participate in benchmarking activities as applicable.
    • 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.
  • Experience
    • 6+ years' experience in Pharmaceutical, Chemical, or Biological Operations with focus on QA processes and underlying regulatory requirements and industry standards/best practices.
  • Specific Skills and Expertise
    • 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
    • Leadership and Project Management skills to ensure successful implementation of projects or initiatives.
  • Language Skills
    • English fluent, written and spoken. Other languages are a plus.
Why Consider Novartis?

We believe the answers are found when curious, courageous, and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's toughest medical challenges.

We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.