Job Description

This position will be located at San Diego site and will not have the ability to be located remotely. This position will require minimal travel as defined by the business (domestic and/or international). The Associate Director Research Quality is responsible for the development, implementation and management of the quality program applicable to the wide range of discovery science and scientific research activities conducted within NIBR globally. Key Responsibilities: Establish research quality standard & compliance monitoring program focusing on internal customer satisfaction and sustained compliance to data quality & integrity standards, policies for Human Tissue use, data privacy and regulatory requirements. Establish a continuous improvement program. Lead evaluation for monitoring the performance of the existing Research & Lab processes and systems for the identification of potential quality and Data Integrity gaps. Work effectively in a matrix environment to develop, propose and implement processes across BR to ensure good data management and sustained compliance. Lead/supervise/participate in the review of research and laboratory project documentation (e.g. Lab notebooks and systems) for both internal processes and external collaborators to assess for Data Quality & Integrity. Provide BR Quality management with reports on the results of the reviews and support issue resolution and closure. Maintain an awareness of quality issues that impact scientific and business objectives. Interact with internal and external departments to provide interpretation of Quality & Compliance information to meet business and regulatory requirements and provide an understanding of how aspects of external requirements may impact the BR organization. Collaborate with BR business partners to support the development of scientific discoveries & research innovation utilizing risk based and mitigation quality processes. Lead and support Quality Due Diligence for Business Development and Licensing Agreements. Review the Quality of the preclinical data for potential assets in the due diligence process and make recommendations to the greater Due Diligence Team. Review industry trends for GxP and non-GxP regulated areas applicable to the NIBR Research areas and recommend appropriate and timely action. In coordination with the Training department and internal customer needs, ensure the required Data quality & Integrity training is established. Establish, report and monitor KPIs related to the program for continuous improvement. Promote a robust quality culture across Non-GxP research & Lab. Train and educate scientists and other QA associates in Data Quality & integrity and quality system requirements, in terms of its content, delivery and strategic importance. Provide expert knowledge in the use of Human Tissue samples in research and have the ability to interpret and provide guidance on country specific regulations. Work in a matrix environment with Legal and Data Privacy to implement the relevant practices. Requirements: Ph.D. in a Scientific and/or Engineering discipline preferred and/or related equivalent experience. Demonstrated experience in a senior Compliance and Quality System role. 10+ years broad experience in a scientific/pharmaceutical industry. Experience in a Biomedical research environment is considered a plus. Strong strategic vision and superior leadership experience including excellent communication, collaboration/consensus building, influencing and negotiation skills. Demonstrated ability to partake or lead cross-functional projects and to effectuate change within a high-performing organization. Experience in coordinating/integrating with a wide range of business functions and success working globally in multi-disciplinary teams. Note: The company will not sponsor visas for this position. Novartis is unable to offer relocation support for this role; please only apply if this location is accessible for you. #J-18808-Ljbffr Novartis Farmacéutica

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