Senior Associate QA, Global Distribution Quality (GDQ)
Core
Oversee global product distribution and transportation from Amgen's Global Supply Hubs to global markets, ensuring compliance with GMP/GDP and managing quality events.
Role type
Senior Associate Quality Assurance (Global Distribution)
Builds
Global supply chain distribution and transportation networks for biopharmaceutical products
Domain
Biotechnology / Pharmaceutical Supply Chain
Deliverable
client delivery
Required skills
GMP/GDP compliance, logistics process management, validation/qualification of processes and facilities, technical writing, risk management, supplier performance assessment, audit support
Preferred skills
Change management, operational improvement initiatives, multi-functional team collaboration
Technologies
Microsoft Office Tools (Excel, Word, PowerPoint)
Responsibilities
Perform QA contact role on Quality Events, Change Control records, and Corrective and Preventive Actions; Act as subject matter expert for transportation related Quality Processes; Prepare, review and approve SOPs and GMP/GDP documentation; Support internal/external audits and inspections; Provide quality expertise and guidance to operational staff; Own supplier metrics and performance assessments
Seniority
Senior, hands-on IC
