Manager Quality Systems & Data Analytics, R&D GMP Quality
Takeda
June 30, 2026
Remote friendly (Lexington, MA)
United States
$103,500 - $162,690 USD yearly
Operations
Title: Manager, Quality Systems & Data Analytics, R&D GMP Quality
Location: Lexington, MA
About the role:
Transform R&D GMP Quality into a proactive, predictive quality organization using advanced analytics, data science, and digital innovation. Develop and deploy predictive models and AI-enabled solutions to identify emerging quality risks, compliance trends, and operational opportunities. Integrate enterprise quality data (e.g., QMS, audits, deviations, CAPAs, inspections, supplier quality, labs, manufacturing, development) and build an analytics ecosystem with business/quality/digital stakeholders.
Responsibilities:
- Develop predictive analytics models to identify potential quality/compliance/operational/supply risks.
- Apply statistical modeling, machine learning, and AI to generate actionable insights.
- Build quality and predictive risk indicators/metrics (leading indicators).
- Discover patterns and emerging trends across deviations, CAPAs, audits, complaints, lab/supplier/manufacturing data.
- Design scalable data science solutions (Databricks, Power BI, Azure, SQL, Python, AI/ML).
- Establish data pipelines, governance, and analytical capabilities.
- Evaluate AI for automating monitoring, signal detection, trend analysis, and processes.
- Create executive visualizations/storytelling and translate findings into recommendations.
- Establish analytics standards, promote data literacy, mentor stakeholders, and ensure governance/privacy/validation/regulatory compliance.
Qualifications (required):
- Bachelor’s in a quantitative field (Data Science, CS, Statistics, Applied Math, Engineering, Analytics, IS, or related).
- 5+ years in data science/advanced analytics/BI (or related).
- Experience supporting Quality/Manufacturing/Supply Chain/R&D.
- AI & predictive analytics experience in quality/operational processes.
- Built predictive models/ML solutions/analytical frameworks; applied statistical modeling in regulated industries.
- Proficient in Python and SQL; modern analytics platforms; visualization/executive storytelling.
Preferred:
- Master’s (Data Science/Analytics/Stats/CS/AI or related).
- 5+ years in pharma/biotech/healthcare/regulation.
- Experience with Databricks, Azure Data Services, Snowflake, Power BI, Tableau, or Qlik; AI/ML frameworks (e.g., scikit-learn, TensorFlow, PyTorch).
- Generative AI/NLP/intelligent automation; knowledge of GxP/pharma quality systems.
Benefits:
- U.S. base salary range: $103,500.00–$162,690.00.
- Possible incentives; medical/dental/vision; 401(k) match; disability/life; tuition reimbursement; volunteer time off; holidays; well-being benefits; up to 80 hours sick time; up to 120 hours paid vacation for new hires.
Location: Lexington, MA
About the role:
Transform R&D GMP Quality into a proactive, predictive quality organization using advanced analytics, data science, and digital innovation. Develop and deploy predictive models and AI-enabled solutions to identify emerging quality risks, compliance trends, and operational opportunities. Integrate enterprise quality data (e.g., QMS, audits, deviations, CAPAs, inspections, supplier quality, labs, manufacturing, development) and build an analytics ecosystem with business/quality/digital stakeholders.
Responsibilities:
- Develop predictive analytics models to identify potential quality/compliance/operational/supply risks.
- Apply statistical modeling, machine learning, and AI to generate actionable insights.
- Build quality and predictive risk indicators/metrics (leading indicators).
- Discover patterns and emerging trends across deviations, CAPAs, audits, complaints, lab/supplier/manufacturing data.
- Design scalable data science solutions (Databricks, Power BI, Azure, SQL, Python, AI/ML).
- Establish data pipelines, governance, and analytical capabilities.
- Evaluate AI for automating monitoring, signal detection, trend analysis, and processes.
- Create executive visualizations/storytelling and translate findings into recommendations.
- Establish analytics standards, promote data literacy, mentor stakeholders, and ensure governance/privacy/validation/regulatory compliance.
Qualifications (required):
- Bachelor’s in a quantitative field (Data Science, CS, Statistics, Applied Math, Engineering, Analytics, IS, or related).
- 5+ years in data science/advanced analytics/BI (or related).
- Experience supporting Quality/Manufacturing/Supply Chain/R&D.
- AI & predictive analytics experience in quality/operational processes.
- Built predictive models/ML solutions/analytical frameworks; applied statistical modeling in regulated industries.
- Proficient in Python and SQL; modern analytics platforms; visualization/executive storytelling.
Preferred:
- Master’s (Data Science/Analytics/Stats/CS/AI or related).
- 5+ years in pharma/biotech/healthcare/regulation.
- Experience with Databricks, Azure Data Services, Snowflake, Power BI, Tableau, or Qlik; AI/ML frameworks (e.g., scikit-learn, TensorFlow, PyTorch).
- Generative AI/NLP/intelligent automation; knowledge of GxP/pharma quality systems.
Benefits:
- U.S. base salary range: $103,500.00–$162,690.00.
- Possible incentives; medical/dental/vision; 401(k) match; disability/life; tuition reimbursement; volunteer time off; holidays; well-being benefits; up to 80 hours sick time; up to 120 hours paid vacation for new hires.