Associate Director R&D Quality Excellence, Analytics, and Innovation
BeiGene
**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.
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