Senior Manager Quality Compliance
Amgen(5 months ago)
About this role
The Senior Manager Quality Compliance External Affairs will lead Amgen’s external engagement to enhance quality, compliance, and regulatory flexibility for Operations, with a regional focus on Japan & Asia Pacific (JAPAC). The role shapes and coordinates input on policy and regulatory requirements related to GMP/GDP and broader GxP expectations, aligning Amgen’s positions with international organizations and regulatory authorities. This position acts as a senior representative for Amgen in external professional bodies and supports cross-functional alignment with Regulatory Affairs-CMC and other internal stakeholders.
Required Skills
- Quality Compliance
- Regulatory Affairs
- GMP/GDP
- Quality Management
- Policy Development
- Stakeholder Engagement
- Training Delivery
- Inspection Trends
- Project Management
- Networking
+2 more
Qualifications
- Master's Degree
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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