Senior Quality Compliance Manager
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Job Description
Quality Compliance Senior Manager leading Amgen’s Quality Intelligence Center. Governing quality signals, risk insights, and compliance oversight for innovative medicines.
Responsibilities:
- Lead the day-to-day operation of the Quality Intelligence Center (QuIC) and manage a professional team responsible for portfolio-level quality monitoring
- Own and continuously improve the QuIC operating model, including review cadence, signal triage, documentation expectations, escalation pathways, action tracking, and governance routines
- Establish review cadences and business standards for evaluating dashboard outputs, quality metrics, trends, anomalies, threshold breaches, and other QuIC-generated signals
- Lead review and prioritization of quality signals to identify issues requiring assessment or follow-up
- Translate deviations, CAPAs, audit and inspection insights, operational metrics, and related evidence into governance-ready summaries, recommendations, and escalations
- Document, escalate, and route significant findings to accountable process owners and cross-functional stakeholders
- Define and propose QuIC business rules, operating standards, documentation expectations, escalation pathways, and workflow requirements
- Partner with R&D Quality, Global Development Operations, and other stakeholders to ensure QuIC insights are understood and acted upon
- Lead process improvements and provide business leadership for QuIC enhancements, including signal definitions, thresholds, business rules, data-quality expectations, training, and adoption activities
- Monitor the effectiveness, timeliness, quality, and capacity of oversight activities and implement practical improvements
- Ensure activities comply with applicable GxP, quality-system, data-governance, and internal procedural requirements
Requirements:
- Doctorate degree and 2 years of Quality experience OR Master’s degree and 4 years of Quality experience OR Bachelor’s degree and 6 years of Quality experience OR Associate’s degree and 10 years of Quality experience OR High school diploma / GED and 12 years of Quality experience
- Bachelor’s degree in scientific, clinical, quality, data, or related discipline, with substantial relevant experience in R&D Quality, clinical development, clinical operations, quality systems, risk management, or centralized monitoring
- Experience leading and developing professional employees or leading complex cross-functional teams
- Experience interpreting quality, operational, or risk data and converting findings into recommendations, escalations, and follow-up actions
- Working knowledge of GCP, quality-risk management, issue management, CAPA and deviation processes, audit and inspection readiness, and quality governance
- Experience as an R&D Quality process owner or in quality oversight across deviations, CAPAs, audits, inspections, management review, or risk-management processes
- Experience with QMS platforms, dashboards, data visualization, data quality, business analysis, user acceptance testing, or digital-product implementation
- Experience with risk-based quality management, centralized monitoring, KRIs, QTLs, CSM, or signal-based quality oversight
- Experience with AI-enabled analytics or digital quality products, including critically evaluating system-generated insights and applying human judgment
- Experience leading operational change in a global matrix environment
- Sponsorship for this role is not guaranteed
Benefits:
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- Discretionary annual bonus program
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible
- Career development opportunities
- Work/life balance support
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