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Global Quality Management Systems Director
hace 2 meses
About the Role
We are seeking a highly experienced and skilled professional to lead our Global Quality Management Systems (QMS) function at Novartis Farmacéutica. As a key member of our organization, you will be responsible for establishing and maintaining a robust QMS network that aligns with our company's quality principles and regulatory requirements.
Key Responsibilities
- Establish and maintain a global QMS network that ensures compliance with GCP, GLP, and GVP regulations and industry standards.
- Drive interactions with cross-functional teams, including GDD, TRD, Country, GMA, NIBR, and Regulatory Affairs, to ensure effective governance and collaboration.
- Represent Novartis Farmacéutica at various boards and meetings, ensuring that feedback from the QMS network is incorporated into global initiatives and projects.
- Act as a key point of contact for GDD, TRD, PV, GMA, NIBR associates on QMS-related matters and serve as a liaison partner in other initiatives and projects.
- Collaborate with process owners to ensure GxP compliance of processes and tools within your remit.
- Author and review QMS documentation, including process descriptions and regulatory assessments.
- Lead and participate in key QMS projects and initiatives, ensuring that quality elements and compliance requirements are addressed.
- Establish and maintain a community of subject matter experts and single points of contact, driving interactions with corresponding functions.
- Develop strong partnerships with key stakeholders and create synergies by leveraging lessons learned and communicating them to stakeholders.
- Participate in benchmarking activities and maintain knowledge of current industry trends and health authority expectations.
Requirements
- 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.
