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Manager Quality Assurance - PQA at Amgen - ApplyBlast

Manager Quality Assurance - PQA

Amgen

1 day ago

3.6 on Glassdoor

Holly Springs, North Carolina, United States

Onsite

Full Time

Manager

0 applicants

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About this role

The Manager Quality Assurance - PQA leads the Plant Quality Assurance team at Amgen's North Carolina facility, overseeing startup activities, operational readiness, and ongoing bulk drug substance manufacturing. This role involves managing QA professionals, ensuring compliance with cGMP and GDP regulations, and driving quality systems integration and continuous improvement. The position requires strong leadership, technical expertise in biotech/pharmaceutical quality assurance, and the ability to support 24/7 operations with shift work after the startup phase.

Responsibilities

Oversee facility startup and transition to ongoing bulk drug substance manufacturing
Manage and develop Quality Assurance professionals to ensure cGMP compliance
Review and approve quality documents, protocols, and change control documents

Skills

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.