Associate Director R&D Quality Excellence, Analytics, and Innovation
This job is no longer available
There are still lots of open positions. Let's find the one that's right for you.
About The Position
The Associate Director R D Quality Excellence, Analytics, and Innovation is a pivotal role within BeiGene, focusing on the enhancement of quality assurance processes across research and development. This position is responsible for implementing a proactive, risk-based approach to Good Clinical Practice (GCP), Good Vigilance Practice (GVP), and Good Laboratory Practice (GLP) Quality Assurance. The role emphasizes the importance of innovation and modernization, particularly through the use of analytics and digital solutions to improve productivity and quality outcomes. The Associate Director will work closely with R D Quality leadership and various cross-functional teams, including IT, Clinical Operations, Data Management, Risk-Based Quality Management (RBQM), and Global Quality, to foster a culture of quality and ensure compliance with regulatory standards. Key responsibilities include the development of risk-based quality strategies and tools, leveraging data analytics and digital innovation to enhance oversight capabilities. The Associate Director will identify opportunities for adopting innovative technologies, such as artificial intelligence and machine learning, and will play a crucial role in educating stakeholders about these capabilities. Additionally, the position involves managing data and metrics to proactively identify regulatory risks and process gaps, participating in quality management reviews, and supporting audit functions to ensure compliance with established standards. The Associate Director will also be involved in continuous improvement initiatives, collaborating with stakeholders to identify trends in quality events and implementing timely risk-based solutions. This role requires a strong understanding of international regulations applicable to clinical trials and pharmacovigilance, as well as the ability to resolve complex problems through in-depth analysis. The position demands excellent communication skills and the ability to work effectively in a dynamic environment, making it essential for the Associate Director to engage with various levels of the organization and represent R D Quality in meetings and discussions.
