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Inspection Readiness Manager at Amgen - ApplyBlast

Inspection Readiness Manager

Amgen

5 months ago

3.6 on Glassdoor

Uxbridge, United Kingdom

Hybrid

Full Time

Senior

0 applicants

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About this role

The Inspection Readiness Manager will lead GCP and IVDR inspection readiness activities across Amgen's clinical portfolio to ensure operational quality and successful regulatory outcomes. This role involves managing inspection preparation tools, driving continuous improvement initiatives, and partnering cross-functionally to strengthen compliance strategies. The individual will serve as a subject matter advisor, maintain inspection documentation repositories, and mentor interns while supporting the Operational Quality team.

Responsibilities

Lead GCP and IVDR inspection readiness activities
Manage inspection readiness tools and regulatory processes
Drive continuous improvement initiatives based on quality trends
Partner cross-functionally to strengthen operational quality
Mentor student interns and support internal audits

Skills

Qualifications

BS in Life SciencesProfessional experience in clinical researchGlobal clinical trial oversight experienceRisk management expertiseMandarin language proficiency

About Amgen

amgen.com

Headquarters

Thousand Oaks, California, United States

Company Size

10001+ employees

Founded

1980

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Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.