Senior Manager R&D Quality Analytics & Portfolio Insights

Role Description

The Senior Manager R&D Quality Analytics & Portfolio Insights is a specialized R&D Quality role focused on applying advanced analytics, statistical methods, and technology-enabled approaches to strengthen independent Quality oversight of clinical development, participant protection, patient safety, and regulated research activities. This position requires practical expertise in clinical and patient-safety Quality and uses data as a means to identify emerging risks, generate actionable quality insights, and support timely, evidence-based decisions by accountable GCP, GVP, GLP, and GCLP Quality Leads.

The role develops, implements, and maintains fit-for-purpose analytical methods and independent oversight-support tools tailored to regulated R&D activities. These may include:

• Statistical monitoring
• Predictive risk models
• Anomaly-detection methods
• Patient-safety and adverse-event reporting analytics
• Data-informed audit packages
• Risk indicators
• Dashboards
• Automated monitoring
• Natural-language tools
• Other scalable capabilities that support Quality by Design, Risk-Based Quality Management, audit and inspection readiness, vendor, process, and system oversight, and targeted risk mitigation

The position integrates and interprets complex clinical, safety, laboratory, monitoring, operational, and quality data to identify study-, site-, subject-, vendor-, process-, product-, and portfolio-level signals that may affect participant protection, patient safety, data integrity, scientific reliability, or regulatory compliance. The role translates these signals into clear insights and recommendations for R&D Quality colleagues and cross-functional partners.

Qualifications

• Experience in pharmaceutical, biotechnology, clinical research, healthcare, or another regulated life-sciences environment
• Demonstrated knowledge of R&D Quality, clinical quality, quality assurance, compliance, risk management, or regulated research and development operations
• Strong working knowledge of GCP and ICH requirements
• Familiarity or experience in GVP, GLP, GCLP, data integrity, computerized-system assurance, and global R&D Quality expectations
• Experience with structured and unstructured data, data mapping, data cleaning, reconciliation, transformation, data modeling, automated quality checks, and data pipelines
• Experience applying statistical analysis, central statistical monitoring, anomaly detection, forecasting, predictive modeling, machine learning, natural-language processing, generative AI, or related methods
• Ability to understand complex R&D Quality and operational processes and translate them into scalable technical solutions
• Ability to communicate technical findings clearly to nontechnical stakeholders

Requirements

• Advanced proficiency with SQL and hands-on proficiency with R or Python
• Experience with Power BI or comparable visualization and business-intelligence platforms
• Experience with statistical programming, central monitoring, anomaly detection, predictive modeling, or machine-learning tools and methods
• Experience with APIs, data warehouses, cloud platforms, ETL/ELT workflows, Git or comparable version-control tools, and analytical development environments
• Experience with automation, natural-language processing, generative AI, or model deployment and monitoring tools is preferred
• Proficiency with Microsoft Office applications; experience with clinical, safety, laboratory, RBQM, audit, and quality platforms is preferred

Benefits

• Comprehensive benefits package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness
• Annual bonus plan for Non-Commercial roles
• Incentive compensation plan for Commercial roles
• Opportunity to own shares of BeOne Medicines Ltd. stock
• Discretionary equity awards and participation in the Employee Stock Purchase Plan

Company Description

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. We look for scientific and business professionals who are highly motivated, collaborative, and share our passionate interest in fighting cancer.