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Global Quality Management Systems Lead
hace 2 meses
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 running the Quality Management Systems (QMS) network for Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and Good Vigilance Practices (GVP) areas.
Key Responsibilities- Develop and implement a comprehensive QMS strategy to ensure compliance with regulatory requirements and industry standards.
- Collaborate with cross-functional teams, including Clinical Development, Regulatory Affairs, and Quality Assurance, to drive QMS-related activities and initiatives.
- Represent the QMS function at various boards and meetings, ensuring feedback from the network is incorporated into global initiatives and projects.
- Act as the primary point of contact for associates on QMS-related topics and serve as a liaison partner for other initiatives and projects.
- Provide subject matter expertise on selected Quality processes and collaborate with the respective QSO/Process owner to ensure GxP compliance.
- Lead and/or participate in key QMS projects or initiatives, ensuring defined quality elements and compliance requirements are addressed.
- Establish and maintain a community/network of Subject Matter Experts or Single Points of Contact and drive interactions with corresponding Functions.
- Develop strong partnerships with key stakeholders and create synergies by leveraging lessons learned and communicating them to the SMEs and stakeholders.
- Stay up-to-date with industry trends and Health Authority expectations.
- 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.
- 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.
At Novartis, we are committed to improving and extending people's lives. We believe that the answers to the world's toughest medical challenges are found when curious, courageous, and collaborative people like you are brought together in an inspiring environment. We empower our people to unleash their full potential and drive innovation through collaboration and bold thinking.
We are an equal opportunities employer and welcome applications from diverse candidates. We are committed to building diverse teams, representative of the patients and communities we serve, and strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
