Senior Manager Corporate Quality Compliance

Join 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. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients while research, manufacture, and deliver innovative medicines. Our award‑winning culture is collaborative, innovative, and science‑based. If you have a passion for challenges and the opportunities that lie within them, you’ll thrive as part of the Amgen team. Join us and transform both the lives of patients and your own career. Global Quality Compliance, Senior Manager What You Will Do Responsible for executing Global Quality Compliance assigned tasks and/or projects necessary to achieve corporate and departmental goals. Responsibilities Coordinate and lead or participate in Global Quality Compliance audits of Corporate Quality Management System, Amgen sites, contract facilities, affiliates, critical service providers, suppliers, partners, and wholesalers to assess compliance with all applicable regulations and to identify top compliance risks. Ensure completion, maintenance, and sustainability of the assigned training per specific roles to support the audit process. Support preparation of the annual audit plans. Assess state of compliance with appropriate regulations and participate in the assessment of action plans to correct deficiencies. Provide technical and organizational leadership toward resolving site and multi‑site compliance issues. Alert executive management of significant quality and compliance risks. Serve as subject‑matter expert on global regulated requirements and inspectional commitments. Provide support for domestic and international regulatory authority inspections when necessary. Act as senior Global Quality Compliance representative on cross‑functional teams (e.g., QMS, GPO, ALF, and special task forces) and interact with other departments to achieve goals. Interact with other functional area leads to ensure that Amgen Standards, strategies, and direction are aligned with existing regulations and regulatory expectations. Provide support for audit and inspection metrics. Support continual improvement initiatives, programs, and projects. Own or perform QA approval for DQMS quality event records (Quality Incident, Deviation, CAPA, Change Control, EV for GQC and Audits & Inspections network as required). Additional Requirements Experience with aseptic processing, drug product, drug substance, combination products, data integrity. Certified Quality Auditor (CQA) or equivalent. Travel: Domestic and International – approximately 50%. What We Expect Of You We seek an employee with the following qualifications: Basic Qualifications Doctorate degree and 2 years of auditor experience OR Masters degree and 6 years of auditor experience OR Bachelors degree and 8 years of auditor experience OR Associate’s degree and 10 years of auditor experience OR High school diploma / GED and 12 years of auditor experience. In addition to meeting at least one of the above requirements, you must have a minimum of 2 years of experience directly managing people and/or leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above. Preferred Qualifications Auditing experience in internal audit, affiliate, CMO, contract laboratory, transportation/logistics/distribution/warehouse services. 50% international travel requirement. Knowledge of international regulations and standards. Auditing certification preferred. Detail oriented. Organizational and multitasking skills. What You Can Expect Of Us Amgen offers a total rewards plan that includes health and welfare plans for staff and eligible dependents, financial plans, work/life balance, and career development opportunities. Benefits also include a comprehensive employee benefits package, discretionary annual bonus program, stock‑based long‑term incentives, award‑winning time‑off plans, and flexible work models. 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 BioSpace