Senior Associate QA, Global Distribution Quality (GDQ)

We are seeking a highly motivated individual for our Global Distribution Quality (GDQ) team to implement and oversee global product distribution and transportation from Amgen’s Global Supply Hubs to Amgen’s global markets, and provide QA oversight of QA activities for Global Supply Chain operations.

Requirements

• Perform QA Contact role on the Quality Events, Change Control records, Corrective and Preventive Actions, as well as QA triage of Distribution complaints.
• Work closely with all relevant partners for the end-to-end process and ensure compliance to GMP/GDP.
• Act as subject matter expert (SME) for transportation related Quality Processes
• Collaborate with the 3rd Parties to ensure alignment to service levels, identifying and implementing performance improvement
• Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations
• Understand and incorporate risk management strategy into overall supply chain strategy
• Provide support for logistic service provider and transportation service provider oversight
• Support in tactical activities for internal/external audits and inspections as part of the audit/inspection team
• Provide quality expertise and guidance to operational staff and within multi-functional Amgen teams
• Take part in operational improvement initiatives, programs, and projects
• Develop solutions that are thorough, practical, and consistent with functional objectives
• Ownership of supplier metrics, performance assessments, and other key documents to inform the health of supplier relationships.

Benefits

• Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards