Senior Manager Corporate Quality Compliance

Global Quality Compliance, Senior Manager Responsible for executing Global Quality Compliance assigned tasks and/or projects necessary to achieve corporate and departmental goals including the following activities. Responsibilities Coordinates and leads or participates 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. Ensures completion, maintenance, and sustainability of the assigned training per specific roles to support the audit process (e.g., read and understand how to apply regulatory requirements including changes to regulations, guidelines and standards, trends and expectations, as applicable). Supports preparation of the annual audit plans. Assesses state of compliance with appropriate regulations and participates in the assessment of action plans to correct deficiencies. Provides technical and organizational leadership toward resolving site and multi‑site compliance issues. Alerts executive management of significant quality and compliance risks. Serves as subject matter expert on global regulated requirements and inspectional commitments, as applicable. Provides support for domestic and international Regulatory Authority Inspections when necessary. Serves as senior Global Quality Compliance representative on cross‑functional teams (e.g., QMS, GPO, ALF, and special task forces) and interacts with other departments to achieve goals. Interacts with other functional area leads to ensure that Amgen Standards, strategies, and direction are aligned with existing regulations and regulatory expectations. Provides support for audit and inspection metrics, as necessary. Supports Continual Improvement initiatives, programs, and projects. Owns or performs QA approval for DQMS Quality Event records (Quality Incident, Deviation, CAPA, Change Control, EV for GQC and Audits & Inspections network as required). Qualifications Basic Qualifications Doctorate degree and 2 years of auditor experience OR Master’s degree and 6 years of auditor experience OR Bachelor’s 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. Minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Additional qualifications: Experience with Aseptic Processing, Drug Product, Drug Substance, Combination Products, Data Integrity; Certified Quality Auditor (CQA) or equivalent. 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 multi‑task skills. Benefits 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, including remote and hybrid work arrangements, where possible. Salary Range: $138,264.40 - $187,063.60 USD 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 Amgen Inc. (IR)