Senior Associate QA, Distribution Quality

Career Category

Quality

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Senior Associate QA, International 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?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s 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 Amgen’s Global Supply Hubs to Amgen’s 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:

• Bachelor’s /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

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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Please note that you should be in your current position for at least 18 months before applying to internal positions. Staff must notify their current manager if invited for an interview. In addition, Staff are ineligible to apply for open positions if (a) their performance is currently being managed on a performance improvement plan (PIP) or other locally utilized formal coaching document or (b) their most recent performance rating was not a “Partially Meets Expectations” or higher. Please visit our Internal Transfer Guidelines for more detailed information

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