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GCP Quality Compliance Manager at Amgen - ApplyBlast

GCP Quality Compliance Manager

Amgen

5 months ago

3.6 on Glassdoor

Cambridge, United Kingdom

Hybrid

Full Time

Senior

0 applicants

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About this role

A GCP Quality Compliance Manager at Amgen provides end-to-end quality support for the development and implementation of risk-based quality assurance strategies for clinical development programs. This role involves overseeing quality management and ensuring compliance for global and local clinical trials by serving as a Subject Matter Expert and supporting various quality activities such as audits, risk management, and regulatory inspection responses.

Responsibilities

Provide proactive end to end quality support for clinical development programs
Oversee quality management and ensure compliance for global and local clinical trials
Serve as the GCP quality SME providing independent quality guidance for trial activities
Support clinical trial teams with quality management activities including deviations and CAPAs
Plan, conduct, and report risk based GCP audits including investigator site audits

Skills

About Amgen

amgen.com

Headquarters

Thousand Oaks, California, United States

Company Size

10001+ employees

Founded

1980

View Profile

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