Senior Manager R&D Quality Analytics & Portfolio Insights
New
J
JobgetherLife Sciences
Based in the United StatesFull-TimeManager
Salary not disclosed
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Job Details
- Required Skills
- PythonSQLETLGCPMicrosoft Power BIData visualizationRRisk ManagementData analytics
Requirements
- Experience in pharmaceutical, biotechnology, clinical research, or a regulated life sciences environment.
- Strong knowledge of R&D Quality, clinical quality, quality assurance, compliance, and risk management.
- Strong understanding of GCP and ICH requirements, with familiarity with GVP, GLP, GCLP, and data integrity.
- Hands-on experience with statistical analysis, central monitoring, anomaly detection, predictive analytics, or machine learning.
- Advanced proficiency with SQL and practical experience using R or Python.
- Experience with Power BI or similar business intelligence and data visualization platforms.
- Familiarity with APIs, cloud platforms, ETL/ELT workflows, data warehouses, and Git.
- Ability to translate complex R&D processes into scalable analytical solutions.
- Strong written, verbal, and presentation skills for technical and non-technical audiences.
- Willingness to travel up to 20%.
Responsibilities
- Partner with R&D Quality leaders and cross-functional stakeholders to identify quality priorities, oversight opportunities, and emerging risks.
- Develop and maintain analytical frameworks, quality indicators, and risk signals aligned with risk-based quality management principles.
- Analyze clinical, safety, laboratory, and operational data to identify study-level, program-level, and portfolio-level trends.
- Create statistical monitoring approaches, predictive models, and automated dashboards to support quality oversight.
- Design and maintain analytical tools using technologies such as SQL, R, Python, and Power BI.
- Establish governance practices for analytical and AI-enabled solutions, including documentation, validation, and access controls.
- Lead analytics initiatives from problem definition through development, implementation, and continuous improvement.
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