Quality Compliance Senior Manager

Amgen•Thousand Oaks, CA

About The Position

The Quality Compliance Senior Manager leads Amgen’s Quality Intelligence Center (QuIC) integrated quality oversight operating model and its governed signal-to-action lifecycle. The role ensures that 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 business standards, review routines, governance inputs, decision pathways, and cross-functional ways of working to embed QuIC into R&D Quality oversight. The role partners with R&D Quality, Global Development Operations, and other stakeholders to ensure QuIC insights are understood and acted upon. It also leads process improvements and business enhancements to QuIC, while ensuring activities comply with applicable GxP, quality-system, data-governance, and internal procedural requirements.

Requirements

Doctorate degree and 2 years of Quality experience, or a Master’s degree and 4 years of Quality experience, or a Bachelor’s degree and 6 years of Quality experience, or an Associate’s degree and 10 years of Quality experience, or a 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 turning 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 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 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 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; route changes requiring controlled approval through the appropriate accountable Quality governance.
Partner with R&D Quality, Global Development Operations, and other stakeholders so 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.

Benefits

Health and welfare plans for staff and eligible dependents.
Financial plans with opportunities to save toward retirement or other goals.
Work/life balance and career development opportunities.
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, or a sales-based incentive plan for field sales representatives.
Stock-based long-term incentives.
Award-winning time-off plans.
Flexible work models where possible.