QA Compliance & Inspection Readiness Lead

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

Job summary

Amgen is seeking a Sr Specialist QA - Compliance to provide site‑level leadership for inspection readiness across manufacturing facilities. You will coordinate readiness for regulatory inspections, internal audits, and customer audits, guiding governance, strategies, and cross‑functional actions to address risks before they impact outcomes.

In this role you will manage inspection logistics, develop tools and playbooks, and drive continuous improvement of quality systems and CAPA processes while

Qualifications

• High school diploma / GED with 12 years of regulatory compliance experience
• Associate’s degree with 10 years of regulatory compliance experience
• Bachelor’s degree with 6 years of regulatory compliance experience
• Master’s degree with 4 years of regulatory compliance experience
• Doctorate with 2 years of regulatory compliance experience
• Bachelor’s Degree in Life Sciences or Engineering with 7+ years related work experience in pharma
• Experience leading or coordinating inspection and audit activities
• Strong knowledge of EU and US cGMPs

Responsibilities

• Maintain continuous inspection-ready state for multi-product GMP manufacturing operations
• Develop and improve site inspection readiness programs, tools, trackers, playbooks, and governance processes
• Coordinate cross-functional readiness plans for Health Authority inspections and major audits
• Support inspection strategy for new product introductions to ensure readiness before filing
• Monitor readiness of quality systems and data integrity controls
• Identify gaps and risks and drive timely remediation with owners
• Facilitate monthly management review
• Develop relationships with stakeholders to ensure effective audit support

Skills

Regulatory compliance

Inspection coordination

Cross-functional collaboration

Data analysis

Quality systems

Problem solving

Education

Bachelor’s degree in Life Sciences or Engineering

Job description

Amgen is seeking a Sr Specialist QA - Compliance to provide site‑level leadership for inspection readiness across manufacturing facilities. You will coordinate readiness for regulatory inspections, internal audits, and customer audits, guiding governance, strategies, and cross‑functional actions to address risks before they impact outcomes.

In this role you will manage inspection logistics, develop tools and playbooks, and drive continuous improvement of quality systems and CAPA processes while