QA Sr. Manager, Quality & Risk Intelligence

At Amgen, quality is more than compliance it is a strategic capability that enables innovation, operational resilience, and trust across the product lifecycle.

This role offers a unique opportunity to influence enterprise-wide GxP risk strategy and advance predictive, preventive, and data-driven quality management capabilities within one of the worlds leading biotechnology companies. You will work at the intersection of quality, innovation, analytics, and operational excellence-helping transform how risks are identified, monitored, and mitigated across the global organization.

If you are passionate about modern quality systems, proactive compliance, and building scalable risk management capabilities that protect patients and enable innovation, this role offers meaningful impact and exceptional career growth opportunities.

In this strategic role, the QA Sr. Manager, Quality Risk Intelligence will lead the development and evolution of Amgen's quality risk intelligence capability, transforming quality and operational data into predictive insights that enable earlier identification, prioritization, and mitigation of emerging GxP risks. This role will serve as the future business product owner for quality risk intelligence capabilities, partnering across Quality, Data AI, Digital Technology, Operations, and other global stakeholders to define risk signals, predictive indicators, governance models, and scalable monitoring solutions.

Specific responsibilities include but are not limited to:

• Develop and maintain risk monitoring strategies to proactively identify emerging quality and compliance risks.
• Define and oversee Key Risk Indicators (KRIs), signal libraries, risk thresholds, and quality intelligence metrics to support data-driven decision making.
• Establish methodologies for identifying leading indicators and weak signals associated with emerging quality risk.
• Partner with Technology, AI, Data Sciences teams to translate quality and risk needs into scalable data products, dashboards, predictive models, and AI-enabled monitoring capabilities.
• Serve as business product owner for future Quality Risk Intelligence capabilities and GxP Control Tower solutions.
• Define business requirements, user stories, and risk intelligence use cases for digital product development.
• Drive adoption and business value realization for risk intelligence products across Quality and Operations.
• Influence strategic decisions through risk insights that support product quality, patient safety, supply continuity, and regulatory compliance.
• Partner with business functions to validate signal relevance and continuously improve predictive performance.
• Foster strong cross-functional collaboration and alignment across global teams and leadership forums.

We are all different, yet we all use our unique contributions to serve patients. The QA Sr. Manager professional we seek is an individual contributor leader with these qualifications:

• Doctorate degree 10 years of Quality experience OR
• Masters degree 16 years of Quality experience AND
• 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.

• 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.