Senior Associate QA, Global Distribution Quality (GDQ)

Position Overview :

Working independently, the Quality Assurance (QA) Contact will be responsible for ensuring compliance with GMP / GDP and performing various QA-related activities, including overseeing quality events, change control records, corrective and preventive actions, and distribution complaints. The role will also include collaboration with third-party vendors to ensure service level alignment, support for logistics providers, and participation in audits and inspections.

Key Responsibilities :

• Quality Event & Change Control :
• Perform the QA Contact role on Quality Events , Change Control records, Corrective and Preventive Actions (CAPAs) , and QA triage of Distribution complaints to ensure compliance with regulations.
• End-to-End Process Compliance :
• Work closely with all relevant partners for the end-to-end process and ensure full compliance with GMP (Good Manufacturing Practices) and GDP (Good Distribution Practices) .
• Subject Matter Expert (SME) :
• Act as a subject matter expert for transportation-related Quality Processes , providing technical and procedural expertise to internal teams.
• 3rd Party Collaboration :
• Collaborate with 3rd parties (e.g., logistics and transportation service providers) to ensure alignment with service levels and to identify opportunities for performance improvement .
• SOP & Documentation Compliance :
• Prepare, review, and approve Standard Operating Procedures (SOPs) and other GMP / GDP documentation, ensuring compliance with corporate, regulatory, and Good Manufacturing Practices (cGMP) requirements.
• Risk Management :
• Understand and incorporate risk management strategies into the overall supply chain strategy to mitigate potential risks.
• Provider Oversight :
• Provide support for logistics service providers and transportation service providers by overseeing their performance and ensuring service compliance.
• Audit & Inspection Support :
• Support internal / external audits and inspections as part of the audit / inspection team, ensuring adherence to regulatory standards.
• Quality Expertise :
• Provide quality expertise and guidance to operational staff and cross-functional teams within Amgen .
• Operational Improvement :
• Take part in operational improvement initiatives , programs, and projects aimed at enhancing efficiency and compliance.
• Supplier Relationship Management :
• Oversee supplier metrics , conduct performance assessments , and manage key documents to maintain strong supplier relationships and identify improvement opportunities.
• Independent Work & Leadership :
• Work with minimal supervision, demonstrating leadership in line with Amgen Values and Leadership Attributes .

Qualifications :

Basic Qualifications & Experience :

What You Can Expect from Us :

At Amgen , we are dedicated to supporting your professional and personal growth, and well-being. As part of our commitment to developing treatments that care for others, we also prioritize your journey every step of the way. We offer :

Skills Required

Documentation, Change Management, External Audit, Data Validation, Inspection