Associate Vice President, Quality

Associate Vice President, Quality What you will do Lets do this. Lets change the world. In this vital role as Associate Vice President, Quality you will report to the Vice President Research and Development Quality (RDQ) Organization. A team of 30‑40 staff will be built to serve Amgen's Research Development Organization. The Associate Vice President, Quality will lead and provide proactive end‑to‑end quality strategies globally for therapeutic areas: Oncology, Inflammation, Cardiovascular, Neuroscience and others. This role will drive the transformation of clinical quality oversight in compliance with ICH E6R3 and enable embedded quality oversight into clinical development teams. Incorporate quality by design principles to ensure quality risk management is identified and mitigated early to drive a high degree of compliance throughout the study conduct. Deliver inspection strategies to ensure successful submissions globally. This role builds collaborative supportive relationships and serves as single point of accountability representing RDQ with the Amgen clinical, research, clinical operations, regulatory and other relevant stakeholders in Research and Development (R&D) and Operations Quality in support of the therapeutic area for which they are responsible. Responsibilities Ensures proper quality oversight strategies of research activities and RBQM in clinical trials. Lead a global team and manage all trials across the Amgen portfolio globally. RDQ has a key role and responsibility in driving embedded quality partnerships across critical R&D programs. RDQ has a key role in advancing data‑driven oversight capability across the organization. Responsible for inspection readiness, inspection execution and follow up. Clinical Expanding our capabilities beyond GCP compliance and audit mindset focus include: Biosimilars Rare Disease Precision Medicine Digital technology Labelling Product Complaint/Safety Reporting PASS Study Management Clinical trial simplification Data analytics Metrics development R&D activities in response to regulatory trends and external pressures Quality and compliance oversight over Amgen General Medicine: cardiovascular, obesity; Oncology, Inflammation and Biosimilar Portfolios RDQ is transforming into an organization that provides quality assurance through proactive quality oversight in clinical trials on quality by design, critical to quality measures and risk‑based quality assurance. Oversight of FSP and ensures performance of vendors is adequately executed for each study. Leads health authority inspection readiness and inspection strategy for clinical globally. Research Expanding our capabilities beyond GLP compliance mindset to include: In‑Vitro and Companion Diagnostics Biomarkers Lab services Digital technology Data analytics Research studies internally and externally sourced. Research vendors including innovative technology vendors, lab facilities. Animal welfare. Health authority inspection readiness and inspection strategy for research. What we expect of you The executive we seek is an experienced leader with the following qualifications. Basic Qualifications Doctorate degree and 7 years of Clinical & Research Quality experience OR Masters degree and 10 years of Clinical Quality experience OR Bachelors degree and 12 years of Clinical Quality experience AND 7 years of managerial experience directly leading people in a multi‑tiered organization and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications Experience leading a Clinical Quality Assurance Team with oversight responsibilities of large clinical trial programs across multiple therapeutic areas. Experience delivering risk‑based quality oversight programs in compliance with ICH guidelines and global regulatory requirements. Working knowledge of the legal and regulatory environment, applicable laws, regulations, guidance, and health authority expectations globally for drug development. Proven track record in management and subsequent response to health authority inspections. Leadership Attributes Inspire: Create a connected, inclusive, and inspiring work environment that empowers talent to thrive. Accelerate: Enable speed that matches the urgency of patient needs by encouraging progress over perfection. Integrate: Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholders. Adapt: Lead through change by adapting to an ever‑changing environment and defining a clear course of action to deliver results. 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. is $266,028 - $359,920. 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 towards retirement or other goals, work/life balance, and career development opportunities that may include: 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 and bi‑annual company‑wide shutdowns. Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies. Equal Opportunity 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 with 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.