Quality Compliance Senior Manager

Amgen Inc.; United States; Hybrid; USD 132,000 - 179,000; Full time

Benefits offered by this job

Retirement plan with company match

Medical, dental & vision insurance

Life & disability insurance

Flexible spending accounts

Discretionary annual bonus program

Stock-based incentives

Generous time-off

Job summary

Amgen Inc. seeks a Quality Compliance Senior Manager to lead the Quality Intelligence Center (QuIC) and oversee an integrated quality oversight model across signals, trends, and dashboards.

This role routes information to governance structures and cross-functional stakeholders to drive timely actions. The position requires strong leadership, experience in quality governance, and the ability to translate complex data into clear recommendations.

Qualifications

• Doctorate or Master's with Quality experience required (see Basic Qualifications).
• Bachelor’s or higher in science/quality fields with progressive experience considered.
• Experience in R&D Quality, CAPA, deviations, audits, and risk management preferred.

Responsibilities

• Lead the QuIC function day-to-day and manage a professional team.
• Own and continuously improve the QuIC operating model and governance routines.
• Define review cadences, thresholds, and escalation pathways for signals and dashboards.
• Translate quality information into governance-ready summaries and actions.
• Ensure documentation and escalation of significant findings to owners and stakeholders.
• Collaborate with R&D Quality and Global Development Operations to act on insights.
• Drive process improvements and adoption of QuIC enhancements.
• Monitor oversight activities for timeliness, quality, and capacity.

Skills

Leadership

Data interpretation

Stakeholder management

Quality governance

Communication

Process improvement

Change management

Education

Doctorate degree

Master’s degree in a related field

Bachelor’s degree in related field

Associate’s degree with extensive Quality experience

Tools

QMS platforms

Dashboards / Data visualization

AI-enabled analytics

Job description

Quality Compliance Senior Manager

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, 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.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well‑being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Salary Range

• 132,037.30USD – 178,638.70 USD

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, 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. Refer to the Work Location Type in the job posting to see if this applies.

Sponsorship

Sponsorship for this role is not guaranteed.

Equal Opportunity & Disabilities

Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

Application Deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.