**General Description:** The Associate Director R&D Quality Excellence, Analytics, and Innovation is responsible for supporting and maintaining a proactive, risk-based, and phase appropriate approach to GCP, GVP and GLP Quality Assurance. This role serves to play a critical role in supporting innovation/modernization and driving change including analytics education/development, process modernization and increasing productivity with innovative digital solutions. A key responsibility will be working collaboratively with R&D Quality leadership and cross-functional partners (IT, Clinical Operations, Data Management, RBQM, and Global Quality.) This position will be implementing and overseeing data analytics and digital solutions that contribute to a culture of quality across research and development by providing digitally enabled, data driven, and risk-based tools and processes. **Essential Functions of the Job:** Support and Oversee R&D Quality activities which include, but are not limited to: + As a member of the R&D Quality Excellence team, contribute to the development of risk-based quality strategy, processes, and tools, and provide expertise and leadership in the areas of data analytics and digital innovation (I.E. Artificial Intelligence, Automation, Data Science.) + Translate near-term and long-term needs into technical solutions to enhance oversight capabilities using basic and advanced analytics capabilities (e.g. through coding, using visualization software, data science). + Support identification of opportunities to adopt innovative technologies (analytics, data science, artificial intelligence, etc.) and advanced analytics/digital solutions (data science, NLP, machine learning, LLM) + Assist in raising awareness and furthering education about data science, data analytics and artificial intelligence capabilities (NLP, machine learning) across Quality. + Liaison with business owners, RBQM, Data Management, and GTS (IT) on analytics projects to develop business requirements, project timelines, aligned business deliverables and support dashboard modernization. + Proactively identifying regulatory risks and process gaps through management of data, metrics, Key performance/Quality Indicators (KP(Q)Is) and development of analytics packages to support these efforts. + Participating in the review of study related metrics (i.e; protocol deviation, etc.) as part of the Quality Management Review (QMR) approach to identify gaps, trends, and the need for process improvements. + Assisting R&D Quality Inspection Management Teams and cross-functional compliance functions, in developing/adjusting adequate Inspection Readiness (IR) Plans and Strategies, based on review of available data/metrics. + Assisting R&D Quality audit functions in developing/adjusting the audit scope/strategy, based on review of data/metrics. + Assisting R&D Quality Internal Audit Team in selection of processes/system for audit and defining scope for selected system/process audits. + Supporting Quality by Design, Risk Based Quality Management initiatives, and other quality improvement initiatives, in collaboration with cross functional partners and stakeholders. + Supporting improvement initiatives for key R&D Quality systems, processes and procedures. + Initiating/assisting/collaborating (in) the development of Quality Improvement (QI) initiatives to ensure data integrity. + Promoting continuous improvement by partnering with key stakeholders to identify trends in quality events and ensure risk-based solutions are implemented in a timely manner and escalated to senior leadership. + Participating and representing R&D Quality in meetings and discussions, as required. + Supporting regulatory intelligence impact assessments on BeiGene processes and procedures. + Writing, reviewing, and approving Quality - documents (e.g., SOP's). **Additional Qualifications:** + At least 8 years of experience in the pharmaceutical, biotech or technology related industry preferred. + Experience with Advanced Analytics (Python, R, SQL) and supporting implementation of IT solutions (dashboards, apps,etc.) + Knowledge in data science and/or data engineering capabilities, including data visualization (PowerBI preferred.) + Understanding of Data Science market development to be able to come up/explore new ways of delivering analytics solutions to increase their value/contribution. + Knowledge of LLM Development, application programming interfaces, designing/building Generative AI Algorithms, and passion to learn new innovative technology. + Knowledge of GCPs, particularly FDA, EMA and ICH requirements preferred. + Strong global knowledge and understanding of international regulations applicable to the conduct of clinical trials and pharmacovigilance preferred. + Ability to resolve complex problems where analysis of situations or data requires an in-depth evaluation of various factors. + Superb attention to detail, excellent review skills and the ability to organize and manage multiple tasks in a fast-paced environment. + Exercise sound and balanced judgment in ensuring that written procedures are followed and in evaluating quality systems, processes, procedures, plans and protocols for compliance. + Other duties as assigned **Supervisory Responsibilities:** This position will include close collaboration with R&D Quality Leadership Team, R&D Quality staff and other Quality Functions. This role will also collaborate closely with GTS (IT), RBQM, GCO, and cross-functional partners across R&D. **Computer Skills** **:** + PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint, Project) + History of working with Veeva QMS System is preferred + Knowledge in data science and/or data engineering capabilities. + Understanding of Data Science/Data Analytics including Advanced Analytics (Python, R, SQL) + Understanding of data visualization tools (PowerBI preferred.) + Knowledge of LLM Development/Application Programming Interfaces (APIs) and designing/building Generative AI Algorithms + Passion to learn new innovative technology. **Other Qualifications:** **Education Required:** Bachelor’s degree, preferably in Science or combination of education and 8+ years equivalent work experience. Or MS with 6+ years experience. **Communication & Interpersonal Skills** + Excellent verbal and written communication skills + Ability to effectively collaborate in a dynamic environment **Significant Contacts** + Quality + Global Technical Solutions + Clinical Operations + Data Management + Risk Based Quality Management + Pharmacovigilance + Clinical Business Operations + Biometrics + Medical Monitors + Regulatory Affairs + Interacts with all levels of BeiGene **Travel:** May require up to 20% travel All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.