Manager Quality Systems & Data Analytics, R&D GMP Quality

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use .  I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Title: Manager, Quality Systems & Data Analytics, R&D GMP Quality Location: Lexington, MA About the role: As a Manager, Quality Systems & Data Science, you will play a critical role in transforming R&D GMP Quality from a reactive compliance-focused organization into a proactive and predictive quality organization through advanced analytics, data science, and digital innovation. You will develop and deploy advanced analytics, predictive models, and AI-enabled solutions that identify emerging quality risks, compliance trends, and operational opportunities before they impact product quality, patients, or regulatory outcomes. You will transform enterprise quality data into actionable insights that enable data-driven decision-making, continuous improvement, and strategic prioritization across R&D GMP Quality. You will lead the development of Quality data science capabilities by integrating data from Quality Management Systems, audits, deviations, CAPAs, inspections, supplier quality, laboratories, manufacturing, and development activities. You will partner up with business, quality, and digital stakeholders to establish a modern analytics ecosystem that supports Takeda's vision of becoming a predictive and performance-driven quality organization. How will you contribute: Quality Intelligence & Advanced Analytics Develop in partnership with R&D Quality Compliance Systems & Data and Digital, Data & Technology (DD&T), predictive analytics models to identify potential quality, compliance, operational, and supply risks before occurrence. Apply statistical modeling, machine learning, and AI methodologies to analyze quality data and generate actionable business insights. Build and maintain quality risk indicators, leading indicators, and predictive metrics that complement traditional lagging KPIs. Identify hidden patterns, correlations, and emerging trends across deviations, CAPAs, audits, complaints, laboratory data, supplier quality, and manufacturing quality systems. Develop advanced analytical frameworks to support quality decision-making, risk assessments, inspection readiness, and continuous improvement initiatives. Data Science & Digital Innovation Design and implement scalable data science solutions leveraging enterprise platforms such as Databricks, Power BI, Azure, SQL, Python, and AI/ML technologies. Partner with R&D Quality Compliance Systems & Data and Digital, Data & Technology (DD&T), business leaders, and quality stakeholders to establish data pipelines, governance models, and analytical capabilities. Evaluate emerging AI technologies and identify opportunities to automate quality monitoring, signal detection, trend analysis, and business processes. Lead proof-of-concept initiatives and pilot programs focused on predictive quality and intelligent automation. Business Insights & Decision Support Translate complex quality findings into clear, actionable recommendations for senior leadership. Deliver executive-level insights that support strategic decision-making, resource prioritization, and performance management. Create advanced visualizations and storytelling tools that communicate business risks, opportunities, and trends effectively. Support organizational transformation initiatives through data-driven identification of efficiency opportunities and process improvements. Analytics Governance & Capability Building Establish standards, methodologies, and best practices for quality analytics and data science across R&D GMP Quality. Promote data literacy and analytical thinking within the organization. Mentor stakeholders on effective use of data, analytics, and visualization tools. Ensure compliance with data governance, privacy, validation, and regulatory requirements. What you bring to Takeda: Bachelor's degree in Data Science, Computer Science, Statistics, Applied Mathematics, Engineering, Analytics, Information Systems, or related quantitative field. Minimum 5 years of experience in data science, advanced analytics, business intelligence, or related discipline. Experience supporting Quality, Manufacturing, Supply Chain, or R&D organizations. Experience applying AI and predictive analytics to quality or operational processes. Demonstrated experience building predictive models, machine learning solutions, and analytical frameworks. Experience applying data science, advanced analytics, or statistical modeling in a regulated industry. Proficiency in Python, SQL, and modern data analytics platforms. Experience in predictive models, machine learning algorithms, and statistical analyses. Experience transforming large, complex datasets into actionable business insights. Strong knowledge of data visualization and executive storytelling techniques. Preferred Master's degree in Data Science, Analytics, Statistics, Computer Science, Artificial Intelligence, or related field. Minimum 5 years of experience within pharmaceutical, biotechnology, healthcare, or regulated industries. Experience with Databricks, Azure Data Services, Snowflake, Power BI, Tableau, or Qlik. Experience with AI/ML frameworks such as Scikit-learn, TensorFlow, PyTorch, or equivalent. Experience with Generative AI, NLP, or intelligent automation solutions. Knowledge of pharmaceutical quality systems, GxP regulations, and quality management processes. Experience supporting digital transformation initiatives. Independently identifies analytical opportunities and develops solutions that influence strategic quality decisions. Recommends predictive risk mitigation strategies based