Senior Specialist, Quality Risk & Governance

Job description

Career CategoryQualityJob DescriptionJoin 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. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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. Senior Specialist, Quality Risk & Governance What you will do Let’s do this. Let’s change the world! At Amgen, quality is more than compliance — it is a strategic capability that enables innovation, operational resilience, and trust across the product lifecycle. We are seeking a Senior Specialist, Quality Risk & Governance to help strengthen and evolve our enterprise GxP Quality Management System through proactive risk management and effective governance practices. This role combines a strong emphasis on Quality Risk Management (60%) with strategic and operational support for GxP Governance (40%), helping ensure enterprise-wide visibility, escalation, decision-making, and continuous improvement across GxP domains. The successful candidate will partner cross-functionally with Quality, Manufacturing, Supply Chain, Regulatory, Clinical, Pharmacovigilance, and Digital organizations to drive a modern, data-driven approach to quality oversight and governance. This position is ideal for a professional who thrives in matrixed environments, enjoys solving complex organizational challenges, and is passionate about advancing proactive quality cultures. This role is preferred to be hybrid, within close proximity to one of our Amgen locations. Remote will be considered if applicable. Quality Risk Management (60%) In this role, you will support the development, execution, and continuous improvement of enterprise GxP Quality Risk Management programs and processes across multiple GxP domains (GMP, GCP, GLP, GVP, GDP, etc.). Key Responsibilities Support implementation and continuous improvement of enterprise Quality Risk Management (QRM) frameworks aligned with global regulatory expectations. Facilitate risk identification, assessment, mitigation, escalation, and monitoring activities across GxP functions and sites. Partner with cross-functional stakeholders to identify emerging compliance and operational risks across the product lifecycle. Support development and monitoring of Key Risk Indicators (KRIs), 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 risk management process integration within Veeva or other quality technology platforms. Support inspection readiness activities and provide SME support during internal audits and regulatory inspections related to risk management processes. Contribute to development of training materials 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%) You will also support enterprise GxP Governance activities designed to strengthen management oversight, process health, accountability, and cross-functional alignment. Key Responsibilities Support execution and continuous improvement of enterprise GxP Governance and Management Review processes. Coordinate governance meetings, governance committee materials, metrics reporting, and follow-up actions. Assist in maintaining governance frameworks, charters, roles/responsibilities, and escalation models. Support preparation of executive-level governance reports and presentations summarizing quality risks, trends, compliance status, and key decisions. Help 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 The future of quality organizations is shifting from reactive compliance toward predictive governance ecosystems — where data, collaboration, and systems thinking enable earlier interventions and stronger resilience. This role sits at the center of that evolution, helping shape how organizations move from isolated quality activities toward integrated enterprise quality intelligence. In many ways, governance and risk are no longer separate disciplines. The organizations that thrive increasingly treat governance as a living nervous system — one that senses weak signals early, learns continuously, and enables faster, wiser decisions across the enterprise. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic individual we seek is a collaborative partner with these qualifications. Basic Qualifications: Doctorate degree and 2 years of Quality, Operations, Manufacturing, Regulatory, Clinical, or related GxP experience in biotechnology, pharmaceutical, or regulated industry experience OR Master’s degree and 4 years of Quality, Operations, Manufacturing, Regulatory, Clinical, or related GxP experience in biotechnology, pharmaceutical, or regulated industry experience OR Bachelor’s degree and 6 years of Quality, Operations, Manufacturing, Regulatory, Clinical, or related GxP experience in biotechnology, pharmaceutical, or regulated industry experience OR Associate’s degree and 10 years of Quality, Operations, Manufacturing, Regulatory, Clinical, or related GxP experience in biotechnology, pharmaceutical, or regulated industry experience OR High school diploma / GED and 12 years of Quality, Operations, Manufacturing, Regulatory, Clinical, or related GxP experience in biotechnology, pharmaceutical, or regulated industry experience Preferred Qualifications: Experience supporting GxP Quality Risk Management programs for Biologics and Devices/Combination Products. Working knowledge of GxP regulations and risk management principles, including ICH Q9 and ISO 14971. Experience leading and/or executing governance forums, management review processes, or quality councils. Ability to develop executive-ready communications, presentations, and strategic narratives tailored to diverse audiences, including C-suite leadership, executive management, and operational teams. 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 matrix