Senior Associate QA, Distribution Quality

What you will do

We are seeking a highly motivated individual for our International Distribution Quality (IDQ) team. This is an incredibly exciting opportunity to join a team of quality professionals in International distribution team.

HOW MIGHT YOU DEFY IMAGINATION

Youve earned your degree. How will you use that achievement to reach your goalsDo more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this relevant role.

Role Description

• The Sr. Associate QA position will implement and oversee global product distribution and transportation from Amgens Global Supply Hubs to Amgens global markets and provide QA oversight of QA activities for Global Supply Chain operations. This role may require working in shifts or extended hours within the same shift.
• Working independently, the individual will be responsible for, but not limited to the following:
• . Serve as QA contact for quality events, change controls, CAPAs, distribution complaints, and batch disposition/release while ensuring end-to-end GMP/GDP compliance.
• Provide expert quality assessment for transportation temperature excursions and distribution deviations, acting as SME for transportation-related quality processes.
• Prepare, review, and approve SOPs and GMP/GDP documentation and actively support internal audits, self-inspections, and regulatory inspections.
• Work closely with internal stakeholders and third-party logistics and transportation providers to ensure service level adherence, oversight, and performance improvement.
• Integrate risk management into supply chain strategies while contributing to operational improvement initiatives, programs, and projects.
• Provide quality guidance across Amgen teams, own supplier performance metrics and assessments, develop practical solutions, and operate with minimal supervision aligned to Amgen Values and Leadership Attributes.
• Highly motivated, detail-oriented self-starter with strong written and verbal communication skills and advanced proficiency in Microsoft Office, Power BI, Smartsheet, and task prioritization.

Basic Qualifications:

• Bachelors /Master''s degree in science or engineering with 5-9 years of professional experience in related fields.
• Understanding of GMP/GDP requirements.
• Familiarity with logistics processes of parcel, transport, and warehousing providers.
• Experience in Validation/Qualification of processes, equipment, and facilities.
• Strong technical writing skills.

Preferred Qualifications:

• Strong background in Global Supply and Distribution Quality with solid GMP/GDP knowledge and understanding of end-to-end pharmaceutical supply chain processes.
• Demonstrates a strong continuous improvement and Lean mindset with excellent analytical, problem-solving, and process visualization capabilities.
• Experienced in leading cross-functional, multi-geography projects with strong change management skills and the ability to work independently or collaboratively under pressure