Job Information
BeiGene Associate Director R&D Quality Excellence, Analytics, and Innovation in Emeryville, California
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.
BeiGene
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