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Quality Compliance, Director at Amgen - ApplyBlast

Quality Compliance, Director

Amgen

2 months ago

3.6 on Glassdoor

Holly Springs, North Carolina, United States

Onsite

Full Time

Director

0 applicants

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About this role

The Director of Quality Compliance will support regulatory compliance deliverables for new or expanded manufacturing sites, providing strategic partnership for Quality Improvement Plans and operational readiness. The role involves leading inspection readiness activities, drafting regulatory communications, and advising on compliance for deviations, new technologies, and continuous improvement initiatives.

Responsibilities

Provide strategic compliance support for new and expanded manufacturing sites
Lead inspection readiness exercises and coordinate regulatory inspections
Draft and review regulatory communications and inspection observation responses
Partner with QA Operational Readiness Team to evaluate remediation strategies
Advise on compliance for new technologies and continuous improvement initiatives

Skills

Qualifications

Bachelor's degreeMaster's degreeDoctorate degree

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.