Senior Specialist, Quality Risk & Governance

Senior Specialist, Quality Risk & Governance Amgen is a biotechnology company dedicated to serving patients with serious illnesses. We pioneer and deliver innovative medicines across oncology, inflammation, general medicine, and rare disease. What you will do In this role, you will strengthen Amgen’s enterprise GxP Quality Management System by combining proactive risk management (60%) with strategic GxP governance support (40%). Your work will provide enterprise‑wide visibility, escalation, decision‑making, and continuous improvement across GxP domains. Quality Risk Management (60%) Support the development, execution, and continuous improvement of enterprise GxP Quality Risk Management frameworks aligned with global regulatory expectations. Facilitate risk identification, assessment, mitigation, escalation, and monitoring across GxP functions and sites. Partner with cross‑functional stakeholders to identify emerging compliance and operational risks across the product lifecycle. Support the development and monitoring of Key Risk Indicators, quality metrics, and risk dashboards to enable proactive decision‑making. Conduct risk trending, signal analysis, and data evaluation to identify systemic issues and opportunities for mitigation. Assist with governance and oversight of enterprise risk registers, risk review forums, and escalation pathways. Collaborate with Digital and Quality Systems teams to support integration of risk management processes within quality technology platforms such as Veeva. Support inspection readiness activities and provide subject‑matter expertise during internal audits and regulatory inspections related to risk management. Contribute to training material development and risk management capability‑building initiatives across the organization. Monitor industry trends, regulatory updates, and emerging technologies related to Quality Risk Management and digital quality transformation. Governance & Management Review (40%) Support the execution and continuous improvement of enterprise GxP Governance and Management Review processes. Coordinate governance meetings, committee materials, metrics reporting, and follow‑up actions. Assist in maintaining governance frameworks, charters, roles/responsibilities, and escalation models. Prepare executive‑level governance reports and presentations summarizing quality risks, trends, compliance status, and key decisions. Ensure alignment between governance processes, enterprise quality objectives, and operational strategies. Collaborate with stakeholders to improve visibility and integration of risks, KPIs, regulatory intelligence, and continuous improvement initiatives across governance structures. Support process harmonization and standardization initiatives across sites and functions. Participate in continuous improvement efforts supporting the GxP Quality Operating Model and enterprise transformation initiatives. Contribute to benchmarking activities and adoption of industry best practices related to governance and management review. Why This Role Matters This role sits at the center of a transformation from reactive compliance to predictive governance. It helps shape how the organization moves from isolated quality activities toward an integrated enterprise‑wide quality intelligence system. What we expect of you We seek a collaborative partner with a track record of influencing cross‑functional, matrixed organizations and a passion for advancing proactive quality cultures. Basic Qualifications Doctorate degree and 2 years of Quality, Operations, Manufacturing, Regulatory, Clinical, or related GxP experience in biotechnology, pharmaceutical, or regulated industry Master’s degree and 4 years of related experience Bachelor’s degree and 6 years of related experience Associate’s degree and 10 years of related experience High school diploma / GED and 12 years of related experience Preferred Qualifications Experience supporting GxP Quality Risk Management for Biologics and Devices/Combination Products Working knowledge of GxP regulations and risk management principles, including ICH Q9 and ISO 14971 Experience leading or executing governance forums, management review processes, or quality councils Ability to develop executive‑ready communications, presentations, and strategic narratives for diverse audiences, including C‑suite leadership Familiarity with quality systems and digital quality platforms such as Veeva Strong analytical skills with experience interpreting quality metrics, trends, and risk signals Experience working in cross‑functional and matrixed organizations; ability to influence non‑direct reporting groups/functions Ability to communicate complex quality or compliance topics clearly across organizational levels Strong organizational, facilitation, and project coordination skills Experience supporting inspections, audits, CAPA, or compliance initiatives Continuous improvement mindset with interest in innovation, digital transformation, and operational excellence What Success Looks Like The successful candidate will help strengthen proactive risk identification and mitigation capabilities, enable effective governance and escalation of critical quality topics, foster collaboration across functions, and contribute to a modern, data‑driven quality organization. Benefits & Compensation The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is $132,037.30 – $178,638.70. Amgen offers a Total Rewards Plan that includes health and welfare plans, retirement and savings plans, discretionary annual bonus, stock‑based incentives, flexible work models, and comprehensive benefits for staff and eligible dependents. Sponsorship Sponsorship for this role is not guaranteed. Equal Opportunity Employer Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. 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