Senior Associate QA, International Affiliates

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.

What you will do

Let’s do this. Let’s change the world. In this vital role you will implement internal collaboration with Amgen’s global quality teams, manufacturing sites, commercial supply chains, Amgen affiliates, warehouses, and external logistic partners in various regions and countries. The role will support right-first-time quality systems activities, a resilient supply network, leverage compliance knowledge, and support continuous improvement initiatives. This role will also be a critical link between cross-functional teams to uphold the integrity and reliability of our quality standards.

Roles and Responsibilities:

• Primarily Perform the QA Contact role on the Product complaint and Distribution Complaint records and support other QMTS records such as Quality Events, Change Control records, Clinical and Commercial Temperature Excursion records, Corrective and Preventive Actions, effectiveness verification, and documentation.

• Manage quality records, including those for complaints, product recalls, and returned goods, ensuring they meet regulatory and organizational standards.

• Support audits, including self-inspections and external vendor audits, ensuring compliance with Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP).

• Demonstrate knowledge of key regulatory guidelines, including c GDP and cGMP for pharmaceutical/ device products.

• Understand and incorporate risk management strategy into the overall supply chain strategy

• Ensure accurate, complete, and timely documentation of quality records, including deviations, CAPA, change controls, and audit findings.

• Develop quality reports and metrics to track key performance indicators (KPIs) related to quality assurance and compliance.

• Identify and lead initiatives for process improvement, driving quality and operational efficiency through structured methodologies.

• Collaborate with cross-functional teams to implement best practices in quality assurance processes, ensuring continuous improvement.

• Participate in training sessions for quality and compliance, promoting an organizational culture of quality excellence

• Communicate effectively with stakeholders, ensuring alignment on quality objectives and compliance needs.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

• Master’s degree and 1 to 3 years of science or engineering and 2+ years of professional experience in related fields OR

• Bachelor’s degree and 3 to 5 years ofscience or engineering and 2+ years of professional experience in related fields OR

• Diploma and 7 to 9 years of science or engineering and 2+ years of professional experience in related fields

• Understanding of GMP/GDP requirements.

• Familiarity with logistics processes of parcel, transport, and warehousing providers.

• Experience in final release and QMTS processes in global markets

• Strong technical writing skills.

Preferred Qualifications:

• Strong continuous improvement mindset and lean practices experience.

• Understanding of end-to-end supply chain business processes.

• Experience in project management across multiple departments and geographies.

• Quick process understanding, insight, and visualizing.

• Strong analytical and problem-solving skills.

• Independent self-starter, able to work autonomously, under pressure, and in teams.

• GMP/GDP knowledge and understanding of pharmaceutical regulations.

• Energetic, detail-oriented, and highly motivated with a “can do” outlook.

• Change management skills.

• Ability to communicate across all levels of the organization.

• Effective written and verbal communication skills.

• Experience with Microsoft Office Tools, including Excel, Word, and PowerPoint.

• Ability to multi-task and prioritize

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.

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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.