Senior Manager R&D Quality Analytics & Portfolio Insights
Core
Senior Manager leading R&D Quality Analytics and Portfolio Insights to apply advanced analytics, statistical methods, and technology-enabled approaches for independent Quality oversight of clinical development, participant protection, patient safety, and regulated research activities.
Role type
Senior Manager, R&D Quality Analytics & Portfolio Insights
Builds
Statistical monitoring tools, predictive risk models, anomaly-detection methods, patient-safety analytics, dashboards, automated monitoring, and natural-language tools for regulated R&D.
Domain
Life Sciences / Clinical Research / Regulated R&D Quality
Deliverable
production ML models | dashboards & analysis
Required skills
Advanced statistics, clinical quality oversight, risk-based quality management (RBQM), data integrity, regulatory compliance (GCP/GVP/GLP/GCLP), data modeling, machine learning, natural language processing, SQL, Python, R, Power BI
Preferred skills
Experience in pharmaceutical/biotech, knowledge of ICH requirements, experience with structured/unstructured data pipelines, familiarity with responsible AI principles
Technologies
SQL, R, Python, Power BI, Generative AI, Natural Language Processing
Responsibilities
Partner with R&D Quality leadership to identify priority quality questions and emerging risks; Develop and maintain key quality indicators, risk indicators, and portfolio surveillance methods aligned with RBQM; Integrate and analyze clinical, safety, laboratory, and operational data to identify study- and portfolio-level signals; Design, develop, and maintain statistical packages, analytical applications, and automated workflows; Ensure analytical solutions are governed through validation, testing, and documentation for inspection readiness; Create executive-ready visualizations and recommendations for cross-functional partners.
Seniority
Senior Manager, hands-on IC with strategic oversight
