QA Sr. Manager, Quality & Risk Intelligence

Amgen; Hyderabad; On-site; INR 2,500,000 - 3,500,000; Full time

Benefits offered by this job

Career growth opportunities

Inclusive global culture

Generous total rewards and work-life—"

Health, finance and wealth benefits

Job summary

Amgen seeks a QA Senior Manager, Quality & Risk Intelligence, to influence enterprise-wide GxP risk strategy and advance predictive, preventive, and data-driven quality management.

You will lead cross-functional teams across Quality and Operations to translate risk insights into scalable data products and AI-enabled monitoring capabilities. This role requires global coverage and strong collaboration.

Qualifications

• Doctorate degree & 10 years of Quality experience.
• 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.

Responsibilities

• 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.

Skills

Quality leadership

Risk analysis

GxP knowledge

Cross-functional collaboration

Communication

Education

Doctorate degree

Master’s degree

Tools

AI/ML

Statistical modeling

BI dashboards

Job description

At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever‑better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

QA Sr. Manager, Quality & Risk Intelligence

This role offers a unique opportunity to influence enterprise‑wide GxP risk strategy and advance predictive, preventive, and data‑driven quality management capabilities. 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.

Responsibilities

• 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.

Qualifications

• Doctorate degree & 10 years of Quality experience
• 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.

Additional Preferred 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.

Benefits

• Vast opportunities to learn and move up and across our global organization.
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act.
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits.

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.