Senior Associate QA, International Affiliates

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. Amgen harnesses the best of biology and technology to fight the world’s toughest diseases and make people’s lives easier, fuller, and longer. We discover, develop, manufacture, and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting edge of innovation, using technology and human genetic data to push beyond what’s known today. We are seeking a highly motivated individual for our Global Distribution Quality (GDQ) team. This is an incredibly exciting opportunity to join a team of quality professionals in the global 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 meaningful role. Senior Associate QA, International Affiliates What You Do The Sr. Associate QA position 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 From You Education and Experiences: We are all different, yet we all use our unique contributions to serve patients. The quality professional we seek is a strong leader with these qualifications: Bachelor’s degree in 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 Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com What You Can Expect Of Us 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. 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. Show more Show less