Senior Associate, R&D Quality Compliance

Amgen SA; United States; Hybrid; USD 95,000 - 135,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Medical, dental and vision coverage

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus

Stock-based long-term incentives

Time-off plans

Flexible work models

Job summary

Amgen is seeking a Senior Associate Quality Compliance to strengthen Amgen’s R&D Quality Management System and provide quality support across all clinical development stages. You will collaborate with RDQ teams, ensure CAPA closure, and manage documentation and metrics to enable inspection readiness.

Qualified candidates bring advanced degrees or equivalent experience and strong knowledge of GCP, GPV, GLP, ICH guidelines, and MS Office.

Qualifications

• Master’s degree; or Bachelor’s with 2+ years of relevant experience; or Associate’s with 6 years; or high school diploma with 8 years.
• Understanding of Clinical R&D activities and Global Regulations.
• Knowledge of GCP/GPV/GLP and regulatory requirements.

Responsibilities

• Strengthen and advance Amgen’s R&D Quality Management System (QMS).
• Provide quality support for Amgen programs at all stages of clinical development.
• Input audit responses into QMS and site inspection data into the Inspection Management System.
• Collaborate with RDQ Compliance Manager and teams to ensure timely CAPA closure and documentation.
• Prepare weekly metric reports highlighting deviations, CAPAs, and inspection findings.

Skills

Attention to detail

Strong interpersonal skills

Excellent written and verbal comms

Professional, proactive demeanor

Ability to work under pressure

Education

Master's degree

Bachelor's degree with 2+ years related experience

Associate's degree with 6 years related experience

High school diploma / GED with 8 years related experience

Tools

Microsoft Office

Job description

Amgen is seeking a Senior Associate Quality Compliance to strengthen Amgen’s R&D Quality Management System and provide quality support across all clinical development stages. You will collaborate with RDQ teams, ensure CAPA closure, and manage documentation and metrics to enable inspection readiness.

Qualified candidates bring advanced degrees or equivalent experience and strong knowledge of GCP, GPV, GLP, ICH guidelines, and MS Office.