Quality Compliance Specialist: AI-Driven RDQ & Inspections

Amgen Inc. (IR); Chicago (IL); Hybrid; USD 89,000 - 121,000; Full time

Benefits offered by this job

Total rewards plan

Stock-based incentives

Retirement plan

Flexible work models

Job summary

Amgen Inc. (IR) is seeking a Senior Associate Quality Compliance to strengthen the RDQ Quality Management System and provide quality support for clinical development programs. The role involves handling audits, deviations, CAPAs, and regulatory communications with a focus on process automation.

You will collaborate with RDQ Compliance Managers and Clinical Study Teams, preparing metrics and ensuring timely documentation. Strong knowledge of GCP, ICH E6R3, and regulatory procedures is essential.

Qualifications

• Master’s degree or Bachelor’s degree with healthcare experience.
• Clinical R&D knowledge and GCP compliance required.
• Knowledge of ICH E6R3 and 21 CFR is preferred.

Responsibilities

• Strengthen and advance Amgen’s RDQ Quality Management System (QMS).
• Provide quality support for programs across clinical development stages.
• Input audit responses into QMS and site inspection data into the IMS.
• Develop and close CAPAs with timely objective evidence.
• Prepare weekly metrics for the General Medicine team and manage logbooks.

Skills

Clinical R&D knowledge

GCP Quality Compliance

ICH E6R3 knowledge

Regulatory submissions

Microsoft Office

Strong communication

Interpersonal skills

Pressure resilience

Education

Master’s degree

Bachelor’s degree + 2 years healthcare

Associate’s degree + 6 years healthcare

High school diploma + 8 years healthcare

Job description

Amgen Inc. (IR) is seeking a Senior Associate Quality Compliance to strengthen the RDQ Quality Management System and provide quality support for clinical development programs. The role involves handling audits, deviations, CAPAs, and regulatory communications with a focus on process automation.

You will collaborate with RDQ Compliance Managers and Clinical Study Teams, preparing metrics and ensuring timely documentation. Strong knowledge of GCP, ICH E6R3, and regulatory procedures is essential.