Senior Manager R&D Quality Analytics & Portfolio Insights

Role: Senior Manager, R&D Quality Analytics & Portfolio Insights, focusing on applying advanced data analytics and statistical methods to enhance independent quality oversight in clinical development, participant safety, and regulated research activities. Responsibilities: develop and implement analytical tools such as statistical monitoring, risk models, anomaly detection, and dashboards; integrate complex clinical, safety, laboratory, and operational data to identify signals affecting participant protection, data integrity, and regulatory compliance; support GxP oversight including GCP, GVP, GLP, and GCLP; translate data insights into actionable recommendations for Quality leadership and cross-functional teams; lead analytics development using SQL, R, Python, Power BI, and emerging AI methods; ensure data quality and governance; collaborate with global R&D stakeholders on risk assessment, oversight gaps, and continuous improvement. Requirements: advanced proficiency in SQL, R, Python, Power BI; experience with statistical programming, anomaly detection, predictive modeling, and AI; 5+ years in pharmaceutical, biotech, or regulated life sciences environments with knowledge of GCP, GVP, GLP, GCLP; strong communication skills for stakeholder engagement; ability to work across global, cross-functional teams. Preferred: experience with automation, natural-language processing, generative AI, and clinical, safety, or quality platforms. Work setup may involve up to 20% travel. The position reports to R&D Quality leadership and supports global quality oversight.