Senior Manager, R&D Quality Analytics, Portfolio Insights

🕒 2 days ago

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting the development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• Apply advanced analytics, statistical methods, and technology-enabled approaches to strengthen independent R&D Quality oversight • Identify emerging risks and generate actionable quality insights for evidence-based decisions by GCP, GVP, GLP, and GCLP Quality Leads • Develop, implement, and maintain analytical methods and oversight-support tools for regulated R&D activities • Integrate and interpret clinical, safety, laboratory, monitoring, operational, and quality data to identify study-, site-, subject-, vendor-, process-, product-, and portfolio-level signals • Partner with R&D Quality leadership and stakeholders to identify priority quality questions, emerging risks, oversight gaps, and intervention opportunities • Conduct cross-study, cross-program, cross-vendor, and cross-process risk analyses • Develop key quality indicators, critical-to-quality factors, quality tolerance limits, risk indicators, thresholds, escalation criteria, and portfolio surveillance methods • Analyze clinical study, safety, pharmacovigilance, laboratory, monitoring, audit, inspection, vendor, system, and quality data • Develop analytics supporting audit planning, patient-safety risk identification, GLP/GCLP oversight, and GVP oversight • Design, develop, test, implement, and maintain statistical packages, analytical applications, dashboards, automated workflows, predictive models, and decision-support tools • Perform data profiling, mapping, cleaning, transformation, reconciliation, and root-cause analysis • Govern analytical and AI-enabled solutions through intended-use documentation, lineage, testing, validation or assurance, access controls, version control, change management, human review, explainability, monitoring, and retirement planning • Create executive-ready visualizations, quality narratives, risk summaries, and recommendations • Support Quality Management Review, portfolio surveillance, RBQM governance, audit planning, inspection readiness, vendor oversight, computerized-system oversight, and continuous improvement • Partner with Clinical Operations, Clinical Development, Data Management, Biometrics, Medical Monitoring, Pharmacovigilance, Regulatory Affairs, laboratory, RBQM, audit, technology, data engineering, and platform teams • Lead or coordinate analytics workstreams from problem framing through benefit realization • Stay current with global R&D regulatory expectations, statistical methods, responsible AI, and emerging technologies • Provide technical leadership, coaching, and work direction to analysts, contractors, interns, vendors, and project teams • Travel up to 20% may be required

🎯 Requirements

• 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 R&D operations • Strong working knowledge of GCP and ICH requirements • Familiarity or experience with GVP, GLP, GCLP, data integrity, computerized-system assurance, and global R&D Quality expectations • Experience with structured and unstructured data, data mapping, cleaning, reconciliation, transformation, modeling, automated quality checks, and data pipelines • Experience applying statistical analysis, central statistical monitoring, anomaly detection, forecasting, predictive modeling, machine learning, NLP, generative AI, or related methods to clinical, safety, research, or quality problems • Ability to translate complex R&D Quality and operational processes into scalable technical solutions • Ability to communicate technical findings to nontechnical stakeholders and produce actionable quality recommendations • Advanced proficiency with SQL • 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 • Proficiency with Microsoft Office applications • Excellent written, verbal, presentation, and interpersonal communication skills • Ability to collaborate across global, cross-functional, clinical, safety, research, quality, data, and technical teams • Ability to handle sensitive or confidential clinical, safety, quality, laboratory, and patient-level information in accordance with applicable requirements • No direct people-management responsibility is required

🏖️ Benefits

• Annual bonus plan eligibility for non-commercial roles • Discretionary equity awards • Employee Stock Purchase Plan • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life insurance • Paid Time Off • Wellness benefits • Remote work arrangement • Technical leadership, coaching, and work-direction opportunities