Quality Compliance Lead — Inspection Readiness

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

Job summary

Amgen Inc. in Rhode Island seeks a Sr Specialist QA – Compliance to lead site inspection readiness for regulatory, internal, and customer audits.

You will develop readiness strategies, govern processes, and coordinate cross-functional responses to inspections, deviations, and CAPAs, ensuring data integrity and compliant operations across manufacturing. The role emphasizes strong leadership, rigorous analysis, and proactive risk remediation, with a focus on cGMP compliance and quality systems,

Qualifications

• Bachelor’s degree with regulatory compliance experience (6+ years)
• Experience leading inspection/audit activities in pharma
• Strong knowledge of cGMP, deviations, CAPAs, change control, and data integrity

Responsibilities

• Provide site-level leadership for inspection readiness across manufacturing facilities.
• Coordinate readiness plans for Health Authority inspections and major audits.
• Support inspection strategies and responses, including document retrieval and interviews.
• Monitor quality systems, deviations, CAPAs, data integrity controls, and regulatory commitments.
• Escalate significant risks and drive cross-functional remediation.

Skills

Regulatory compliance

Audit readiness

Quality systems

Cross-functional leadership

Data analysis

Education

Bachelor's degree in Life Sciences or Engineering

Job description

Amgen Inc. in Rhode Island seeks a Sr Specialist QA – Compliance to lead site inspection readiness for regulatory, internal, and customer audits.

You will develop readiness strategies, govern processes, and coordinate cross-functional responses to inspections, deviations, and CAPAs, ensuring data integrity and compliant operations across manufacturing. The role emphasizes strong leadership, rigorous analysis, and proactive risk remediation, with a focus on cGMP compliance and quality systems,