Senior Specialist, Quality Risk & Governance

Senior Specialist, Quality Risk & Governance 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. What you will do 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.). 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. 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 Masters degree and 4 years of Quality, Operations, Manufacturing, Regulatory, Clinical, or related GxP experience in biotechnology, pharmaceutical, or regulated industry experience OR Bachelors degree and 6 years of Quality, Operations, Manufacturing, Regulatory, Clinical, or related GxP experience in biotechnology, pharmaceutical, or regulated industry experience OR Associates 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 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 Help strengthen proactive risk identification and mitigation capabilities across the enterprise. Enable effective governance and escalation of critical quality topics. Foster collaboration and alignment across Quality, Operations, and business functions. Contribute to development of a modern, data‑driven quality organization capable of anticipating emerging risks and adapting to evolving regulatory expectations. 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 will 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. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save toward retirement or other goals, work/life balance, and career development opportunities that may include: 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 A 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. 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. Please contact us to request accommodation. #J-18808-Ljbffr Initial Therapeutics, Inc.