Sr Specialist Quality Compliance

BioSpace; West Greenwich (RI); On-site; USD 90,000 - 150,000; Full time

Job summary

Amgen in the United States is seeking a Sr Specialist QA - Compliance to lead site-level readiness for regulatory inspections across manufacturing facilities, and to manage audit readiness and inspection logistics.

You will coordinate schedules, escorts, SME support, document retrieval, and communications, while guiding cross-functional teams to address risks before inspections occur. The role requires decisive action and strong judgment in a dynamic environment to ensure quality and compliance.

Responsibilities

• Lead site-level readiness for regulatory inspections across manufacturing facilities, driving a sustained state of inspection readiness and coordinating audits.

Job description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity‑related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.J

Sr Specialist QA - Compliance

What you will do

Lets do this. Lets change the world. In this vital role, you will provide site-level leadership for inspection readiness across both manufacturing facilities, driving a sustained state of readiness for regulatory inspections, corporate and internal audits, and customer audits. You will lead the development and execution of readiness strategies, establish clear governance and accountability, and influence cross‑functional partners to identify and address risks before they affect inspection outcomes. As a primary site coordinator, you will oversee inspection logistics including schedules, rooms, escorts, subject matter expert support, document retrieval, communications, and daily inspection management while adapting plans and resources as inspection priorities evolve. This role requires sound judgment, decisive action, and the ability to pivot quickly in a dynamic environment, align leaders and teams under time‑sensitive conditions, and escalated emerging issues with clear