Quality Compliance Senior Manager
Amgen
Summary
The Senior Manager leads the Quality Intelligence Center (QuIC) integrated quality oversight operating model and the governed signal-to-action lifecycle through which QuIC-generated signals, trends, dashboard outputs, and emerging quality insights are reviewed, contextualized, triaged, routed, monitored, and closed. The role leads the QuIC team and establishes business standards, review routines, governance inputs, decision pathways, and cross-functional ways of working required to embed QuIC into R&D Quality oversight.
Job description
Key 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 clear, governance-ready summaries, recommendations, and escalations.
- Ensure that 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.
Basic Qualifications
- 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
Preferred Qualifications
- 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.
- 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 the ability to critically evaluate system-generated insights and apply appropriate human judgment.
- Experience leading operational change in a global matrix environment.
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
- 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 the ability to critically evaluate system-generated insights and apply appropriate human judgment
- Experience leading operational change in a global matrix environment
Benefits
- Retirement and Savings Plan
- Group Medical Coverage
- Dental Coverage
- Vision Coverage
- Life Insurance
- Disability Insurance
- Flexible Spending Accounts
- Discretionary Annual Bonus
- Stock-Based Long-Term Incentives
- Time-Off Plans
- Flexible Work Models
Company overview
Amgen Inc. is a leading American multinational biopharmaceutical company headquartered in Thousand Oaks, California, founded in 1980. As one of the world's largest independent biotechnology companies, Amgen specializes in discovering, developing, manufacturing, and delivering innovative human therapeutics. The company focuses on six key therapeutic areas: inflammation, oncology/hematology, bone health, cardiovascular disease, nephrology, and neuroscience. Amgen's portfolio includes blockbuster drugs such as Enbrel for autoimmune diseases, Prolia and XGEVA for osteoporosis, Repatha for cholesterol management, Otezla for psoriasis, and Neulasta for chemotherapy-induced neutropenia. With approximately 28,000 employees worldwide, Amgen operates as a component of both the Dow Jones Industrial Average and Nasdaq-100 indices. The company maintains a robust research and development pipeline with numerous clinical programs across various stages, leveraging cutting-edge biotechnology and human genetic data to address some of the world's most challenging diseases. Amgen's manufacturing capabilities span multiple global locations, and it distributes products through pharmaceutical wholesale distributors and direct-to-consumer channels.