Associate Director R&D Quality Excellence, Analytics, and Innovation

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

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

BeiGene Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

BeiGene is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process.  Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeiGene Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.