Quality Compliance Senior Manager

Amgen • Thousand Oaks, CA

4d • $132,037 - $178,639

About The Position

The Quality Compliance Senior Manager leads Amgen’s Quality Intelligence Center (QuIC) integrated quality oversight operating model and the governed signal-to-action lifecycle. The role oversees how QuIC-generated signals, trends, dashboard outputs, and emerging quality insights are reviewed, contextualized, triaged, routed, monitored, and closed.

The Senior Manager leads the QuIC team and establishes the business standards, review routines, governance inputs, decision pathways, and cross-functional ways of working needed to embed QuIC into R&D Quality oversight. The position partners with R&D Quality, Global Development Operations, and other stakeholders, and ensures oversight 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.

Nice To Haves

• Bachelor’s degree in a 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.
• Demonstrated experience leading and developing professional employees or leading complex cross-functional teams.
• Strong experience interpreting quality, operational, or risk data and converting findings into clear 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.
• Strong communication, stakeholder-management, organizational, and decision-making skills.
• 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 working with AI-enabled analytics or digital quality products, including critically evaluating system-generated insights and applying appropriate human judgment.
• Experience leading operational change in a global matrix environment.

Responsibilities

• Lead the day-to-day operation of the QuIC function 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 consistent review cadences and business standards for evaluating dashboard outputs, quality metrics, trends, anomalies, threshold breaches, and other QuIC-generated signals.
• Lead the review and prioritization of dashboard outputs, quality metrics, trends, anomalies, and threshold breaches to identify issues requiring further assessment or follow-up.
• Translate complex quality information—including deviations, CAPAs, audit and inspection insights, operational metrics, and related evidence—into governance-ready summaries, recommendations, and escalations.
• Ensure significant findings are appropriately documented, escalated, and routed to accountable process owners and cross-functional stakeholders.
• Define and propose QuIC business rules, operating standards, documentation expectations, escalation pathways, and workflow requirements; ensure changes requiring controlled approval are reviewed through the appropriate accountable Quality governance.
• 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 where needed.
• Ensure activities comply with applicable GxP, quality-system, data-governance, and internal procedural requirements.

Benefits

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• Discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models where possible.
• Career development opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: High school or GED