Sr Specialist QA - 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. 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.

Let’s do this. Let’s change the world. In this vital role you will coordinate all site logistics for regulatory inspections, corporate audits, internal audits, and customer audits across both manufacturing facilities. Also serve as a primary site coordinator for inspection readiness activities, including planning rooms, schedules, escorts, subject matter expert support, document retrieval processes, communications, and daily inspection management.

• Partner across functions to maintain a continuous inspection‑ready state for a multi-product GMP manufacturing operation.
• Develop, maintain, and continuously improve site inspection readiness programs, tools, trackers, playbooks, and governance processes.
• Coordinate cross-functional readiness plans for upcoming Health Authority inspections and major audits, including mock inspections, war-room preparation, document review, and interview readiness.
• Support inspection and audit strategy for new product introductions to ensure new processes, facilities, systems, documents, and personnel are inspection ready prior to implementation and filing-related activities.
• Ensure inspection-related commitments, actions, and deliverables are clearly assigned, tracked to completion, and escalated as needed.
• Facilitate cross-functional alignment on inspection narratives, site presentations, supporting data packages, and response coordination.
• Support preparation and maintenance of core inspection readiness content, including site overviews, facility maps, product flow summaries, SME rosters, document inventories, and inspection support tools.
• Coordinate document management and retrieval processes to support efficient and controlled responses during inspections and audits.
• Monitor readiness of quality systems and operational processes that are commonly scrutinized during inspections, including deviations, CAPAs, change control, complaints, training, validations, document management, and data integrity controls.
• Identify gaps, risks, or weak points that may affect inspection outcomes and work with functional owners to drive timely remediation.
• Support site self-assessments and gap assessments against cGMP requirements, internal standards, and regulatory inspection trends.
• Develop and sustain close working relationships with internal stakeholders and external business partners, to ensure aligned and effective audit and inspection support.
• Ensure lessons learned from prior inspections, audits, commitments, and industry enforcement actions are incorporated into site readiness activities.
• Track regulatory commitments and support timely follow-up to ensure inspection observations, actions, and commitments are completed and sustainable.
• Provide compliance support during inspections, including schedule management, room coordination, request tracking, communication support, and facilitation of cross-functional issue resolution.
• Support drafting, coordination, and review of inspection responses and related action plans, as applicable.
• Escala…