Quality Assurance Senior Manager, Plant QA
Amgen(1 month ago)
About this role
The Quality Assurance Senior Manager, Plant QA at Amgen will lead the Drug Substance Plant QA team and serve as the Quality Leader for GMP operations at a commercial drug substance manufacturing facility. The role focuses on building a strong QA organization, establishing plant quality processes, and ensuring product is produced in alignment with quality standards and regulatory filings. The position is part of the Drug Substance QA leadership team and contributes to the safety and quality culture across the site.
Required Skills
- Quality Management
- GMP
- Staff Management
- Leadership
- Change Control
- Risk Management
- Product Disposition
- Investigations
- CAPA
- Auditing
+5 more
Qualifications
- High School Diploma/GED
- Associates Degree
- Bachelors Degree
- Masters Degree
- Doctorate Degree
- 2+ Years Management Experience
- Degree in Life Science or Engineering (Preferred)
About Amgen
amgen.comAmgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.
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