Inspection Readiness Lead - Quality Compliance

Amgen; West Greenwich (RI); On-site; USD 132,000 - 179,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Stock-based long-term incentives

Flexible work models

Job summary

Amgen in the United States is seeking a Sr Specialist QA - Compliance to lead site-level inspection readiness across GMP manufacturing facilities, guiding readiness for regulatory inspections, internal audits, and customer audits. You will develop readiness strategies, coordinate cross-functional plans, manage documents, support interactions with health authorities, and track corrective actions.

Strong judgment, decisive action, and collaboration with stakeholders are essential to protect

Qualifications

• Experience coordinating inspection and audit activities in pharmaceutical manufacturing.
• Strong knowledge of cGMP and quality systems.
• Ability to work autonomously and lead cross‑functional remediation.

Responsibilities

• Provide site‑level leadership for inspection readiness across manufacturing facilities.
• Develop and execute readiness strategies, governance, and accountability.
• Coordinate cross‑functional readiness plans for Health Authority inspections and major audits.
• Support drafting, coordination, and review of inspection responses and action plans.

Skills

Leadership

Communication

Regulatory mindset

Education

Bachelor’s Degree in Life Sciences or Engineering

Master’s Degree in Life Sciences or Engineering

Job description

Amgen in the United States is seeking a Sr Specialist QA - Compliance to lead site-level inspection readiness across GMP manufacturing facilities, guiding readiness for regulatory inspections, internal audits, and customer audits. You will develop readiness strategies, coordinate cross-functional plans, manage documents, support interactions with health authorities, and track corrective actions.

Strong judgment, decisive action, and collaboration with stakeholders are essential to protect