Senior QA Compliance - Inspection Readiness Lead

Biopharma Careers; West Greenwich (RI); Hybrid; USD 132,000 - 179,000; Full time

Job summary

Amgen is seeking a Sr Specialist QA – Compliance to coordinate regulatory inspections and audits across manufacturing facilities. You will lead inspection readiness programs, manage documents, plans, and coordination with SMEs and cross‑functional teams to ensure timely and compliant responses.

The role requires extensive regulatory compliance experience, strong knowledge of cGMPs, and the ability to navigate complex audits and quality systems.

Qualifications

• Bachelor’s degree in Life Sciences or Engineering preferred (see qualifications).
• Extensive regulatory compliance experience in a pharmaceutical/manufacturing setting.
• Experience auditing and defending processes during Health Authority inspections.
• Strong knowledge of EU/US cGMP and quality systems.

Responsibilities

• Coordinate site logistics for regulatory inspections, corporate audits, internal audits, and customer audits.
• Serve as primary site coordinator for inspection readiness activities (planning rooms, schedules, escorts, SME support).
• Develop and maintain inspection readiness programs, tools, trackers, and governance processes.
• Support inspection strategy for new product introductions ensuring readiness before filing actions.
• Ensure commitments and actions are tracked and escalated as needed.
• Prepare and review inspection responses and related action plans.

Skills

Regulatory compliance

Quality systems

Auditing

cGMP

Documentation

Education

High school/GED with 12 yrs exp

Associate degree with 10 yrs exp

Bachelor's degree with 6 yrs exp

Master's degree with 4 yrs exp

Doctorate with 2 yrs exp

Job description

Amgen is seeking a Sr Specialist QA – Compliance to coordinate regulatory inspections and audits across manufacturing facilities. You will lead inspection readiness programs, manage documents, plans, and coordination with SMEs and cross‑functional teams to ensure timely and compliant responses.

The role requires extensive regulatory compliance experience, strong knowledge of cGMPs, and the ability to navigate complex audits and quality systems.