QA Compliance Lead for Inspection Readiness & Audits

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

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.