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AmgenPosted 1 month ago

QA Sr. Manager, Quality & Risk Intelligence

On-siteHyderabad, Telangana, India

Full TimeSenior LevelEnterprise

Job Summary

Develop and maintain risk monitoring strategies to proactively identify emerging quality and compliance risks by defining Key Risk Indicators, signal libraries, and quality intelligence metrics. Partner with Technology, AI, and Data Sciences teams to translate quality needs into scalable data products, dashboards, and AI-enabled monitoring capabilities. Serve as the business product owner for Quality & Risk Intelligence capabilities and GxP Control Tower solutions, driving adoption and value realization across global teams. Influence strategic decisions through risk insights supporting product quality, patient safety, and regulatory compliance. Provide business-need-based coverage across US time zones including Pacific Time.

Required Qualifications

  • Doctorate degree & 10 years of Quality experience OR Master's degree & 16 years of Quality experience
  • 4 years of leading quality initiatives or processes across a global network
  • English language fluency
  • Experience in a pharmaceutical/drug/device manufacturing environment
  • Ability to provide business-need-based coverage across US time zones, including the Pacific Time Zone

Desired Qualifications

  • Advanced expertise in Quality Risk Management (QRM) principles, ICH Q9 and ISO 14971 application within GxP environments
  • Strong analytical mindset with ability to evaluate data-driven risk signals and business outcomes
  • Experience designing or leading enterprise risk monitoring or quality surveillance frameworks
  • Experience working with AI, machine learning, statistical modeling, or advanced analytics teams to solve business problems
  • Experience defining metrics, KRIs, dashboards, or performance monitoring frameworks
  • Experience with digital quality platforms, risk management tools, business intelligence dashboards, and quality analytics capabilities
  • Experience leveraging quality, operational, or compliance data to identify trends, risks, or performance opportunities

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