Quality Compliance Senior Manager

Amgen; United States; On-site; USD 150,000 - 180,000; Full time

Job summary

Amgen is seeking a Quality Compliance Senior Manager to lead the Quality Intelligence Center (QuIC) and drive integrated quality oversight across R&D Quality. You will establish governance, set review cadences, triage signals, and translate complex data into actionable recommendations for cross-functional stakeholders.

The role requires strong leadership, experience with GxP and CAPA processes, and a track record of building scalable quality governance.

Qualifications

• Bachelor's degree in scientific, clinical, quality, data, or related discipline with substantial quality experience in R&D Quality, clinical development, 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 and escalations.
• Working knowledge of GCP, quality-risk management, CAPA and deviation processes, audit and inspection readiness, and quality governance.

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.

Skills

Leadership

Quality oversight

Data interpretation

Communication

Decision making

Stakeholder management

GxP knowledge

Education

Doctorate degree

Master's degree

Bachelor's degree

Associate's degree

High school diploma / GED

Tools

QMS platforms

Job description

Career Category

Quality

Job Description

Join Amgen's Mission of Serving Patients

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.

Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer.

As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Quality Compliance Senior Manager

What you will do

Let's do this! Let's change the world! 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.

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.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

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