Quality Intelligence Oversight Senior Manager

Amgen; Stati Uniti; In loco; USD 150.000 - 180.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Leadership

Quality oversight

Data interpretation

Communication

Decision making

Stakeholder management

GxP knowledge

Formazione

Doctorate degree

Master's degree

Bachelor's degree

Associate's degree

High school diploma / GED

Strumenti

QMS platforms

Descrizione del lavoro

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.