Senior Investigator – Regulatory Compliance & Inspections

Amgen SA; Holly Springs (NC); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Retirement plan

Medical, dental and vision coverage

Life and disability insurance

Flexible spending accounts

Job summary

Amgen North Carolina seeks a Senior Specialist – Investigations & Regulatory Inspections to lead major deviation investigations, coordinate inspection readiness, and partner with cross-functional teams to ensure regulatory compliance and robust quality systems.

The role emphasizes expert root-cause analysis, CAPA development, and effective communication with leadership and inspectors, ensuring timely closures and continuous improvement.

Qualifications

• Doctorate or equivalent with related experience in investigations and quality systems.
• Master’s degree with related experience in investigations and quality systems.
• Bachelor’s degree with related experience in investigations and quality systems.
• Associate’s degree with 10 years of related experience in investigations and quality systems.
• High school diploma with 12 years of related experience in investigations and quality systems.

Responsibilities

• Manage the site's most complex major deviation investigations with teams and CAPA development.
• Prepare inspections and audits ensuring investigations/documentation are inspection-ready.
• Coordinate inspection strategy and war-room activities during regulatory inspections.
• Author/review inspection responses, commitments, and remediation plans.
• Provide consultation on complex investigations for regulatory compliance and inspection readiness.
• Develop investigation narratives and supporting materials communicating history and root cause.

Skills

Project management

Communication

Cross-functional collaboration

Regulatory inspections

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma

Tools

Veeva QMS

Job description

Amgen North Carolina seeks a Senior Specialist – Investigations & Regulatory Inspections to lead major deviation investigations, coordinate inspection readiness, and partner with cross-functional teams to ensure regulatory compliance and robust quality systems.

The role emphasizes expert root-cause analysis, CAPA development, and effective communication with leadership and inspectors, ensuring timely closures and continuous improvement.