Senior Quality Compliance Manager

🔥 18 hours ago

🇺🇸 United States – Remote

💵 $132k - $178.6k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $28.5G Post-IPO Debt on 2022-12

Healthcare • Biotechnology • Pharmaceuticals

Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.

📋 Description

• Lead the day-to-day operation of the Quality Intelligence Center (QuIC) 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 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 quality signals to identify issues requiring assessment or follow-up • Translate deviations, CAPAs, audit and inspection insights, operational metrics, and related evidence into governance-ready summaries, recommendations, and escalations • Document, escalate, and route significant findings to accountable process owners and cross-functional stakeholders • Define and propose QuIC business rules, operating standards, documentation expectations, escalation pathways, and workflow requirements • 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 • Ensure activities comply with applicable GxP, quality-system, data-governance, and internal procedural requirements

🎯 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 • Experience leading and developing professional employees or leading complex cross-functional teams • Experience interpreting quality, operational, or risk data and converting findings into 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 • 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 with AI-enabled analytics or digital quality products, including critically evaluating system-generated insights and applying human judgment • Experience leading operational change in a global matrix environment • Sponsorship for this role is not guaranteed

🏖️ 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 • Flexible spending accounts • Discretionary annual bonus program • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible • Career development opportunities • Work/life balance support