Job
Description
Summary Lead and manage a team within the global TRD QA Compliance organization, responsible for driving compliance activities and projects across TRD, and providing compliance-related services from a centralized location to all TRD sites with GMP capabilities (testing and/or manufacturing). Supports local compliance teams at TRD sites in accordance with their needs and the strategy and objectives of the global TRD QA and TRD QA Compliance organization and drives aligned compliance strategies across sites. Develop strategies for compliance-related projects, processes and tools in alignment with relevant stakeholders from TRD, TRD QA, and other compliance units within Novartis. About the Role Key Responsibilities Lead and manage the team, budget and resources to meet defined objectives. Ensure timely and proactive communication of any issues or challenges to next-level manager. Develop team members ensuring their readiness to drive and support compliance activities in alignment with the TRD QA strategy and objectives. Active member of TRD QA Compliance Network, presenting compliance topics, assisting local compliance teams with issues resolutions, simplifying processes and ensuring excellence in the services provided. Ensure and facilitate active involvement of other team members. Represent TRD QA in global and/or cross-functional compliance related projects, networks and initiatives, ensuring appropriate oversight with strong quality guidance, scientific and technical expertise. Develop or contribute to the strategy of compliance-related projects, processes and tools, including contingency planning and risk assessment as required. Ensure that the strategy implemented aligns with TRD QA strategy and objectives, and complies with cGMP guidelines and internal procedures. Ensure timely communication of the overall project strategy, key issues, and other critical topics to management, project lead, and relevant team members. Proactively manage compliance-related interactions between TRD QA and other stakeholders within TRD and/or Novartis (e.g., RDQ, Global Quality). Closely collaborate with TRD business compliance roles (e.g., GMP officers) and drive alignment across sites. Coach, guide and mentor stakeholders outside TRD QA Compliance organization. Key compliance accountabilities include support to documentation management, quality monitoring, and involvement in projects and life-cycle activities related to compliance IT tools. Minimum Requirements: M.Pharm/ Masters in science 10-14 years of experience Commitment to Diversity and Inclusion: Accessibility and accommodation Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:
