Global Quality Management Systems Lead

hace 7 días

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. The successful candidate will be responsible for establishing and maintaining a robust Quality Management System (QMS) that aligns with global regulatory requirements and industry standards.

Key Responsibilities
  • QMS Governance
    • Establish and maintain a QMS network for GCP, GLP, and GVP areas.
    • Drive interactions with GDD, TRD, Country, GMA, NIBR, and Regulatory Affairs Functions through a defined governance model.
  • QMS Alignment
    • Align with other Business functions within the GCP, GLP, and GVP areas on QMS related activities.
  • QMS Representation
    • Represent global QMS at various boards/meetings in the GCP, GLP, and GVP areas.
    • Ensure feedback from the network is taken into account in global initiatives or projects.
  • QMS Expertise
    • 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.
  • Process Ownership
    • Act as Process Owner for designated processes to drive process lifecycle management.
    • Develop and maintain QMS documentation.
  • Project Leadership
    • Lead and/or participate in key QMS projects or initiatives.
    • Ensure defined quality elements and compliance requirements are addressed.
    • Complete all required activities for successful and timely execution.
    • Roll out to impacted local entities across Novartis.
  • Stakeholder Management
    • Establish and maintain a community/network of Subject Matter Experts or Single Points of Contact.
    • Drive interactions with corresponding Functions.
  • Knowledge Management
    • Create synergies and opportunities by leveraging lessons learned.
    • Communicate them to the SMEs and stakeholders as applicable.
  • Industry Trends
    • 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.
  • Experience
    • 6+ years' experience in Pharmaceutical, Chemical, or Biological Operations with focus on QA processes and underlying regulatory requirements and industry standards.
  • Skills
    • Senior expert level understanding of GxP regulations and guidelines.
    • Solid understanding of health authority expectations and industry trends.
    • Leadership and Project Management skills.
    • Curiosity and agility to adapt to a fast-moving environment.
  • Language
    • English fluent, written and spoken. Other languages are a plus.
About Novartis

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 of healthcare.

We believe that our employees are our greatest asset and are committed to providing a work environment that is inclusive, diverse, and supportive of our employees' growth and development.

We are an equal opportunities employer and welcome applications from all qualified candidates.

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