Join Amgen’s Mission of Serving Patients
At Amgen, you're part of something bigger. Our mission—to serve patients living with serious illnesses—drives everything we do. Since 1980, we've been pioneers in biotech, focused on four key therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease. Every year, we reach millions of patients. By joining the Amgen team, you’ll contribute to groundbreaking innovations that improve lives while also advancing your career.
What You Will Do
Let’s make an impact together. As a Product Quality Leader (PQL) at Amgen, you will provide strategic leadership, technical expertise, and project direction within the Product Quality (PQ) organization. The PQL works closely with teams across Amgen, including International Quality, Regulatory, Quality Control, and others, to resolve issues related to manufacturing, process controls, analytical methods, specifications, reference standards, investigations, and regulatory submissions. You will drive operational efficiency, corporate alignment, and manage product quality through its lifecycle.
This position involves overseeing the product quality for pivotal and/or commercial products, ensuring timely data review, ownership of GMP documents, regulatory filings, and providing leadership to the Product Quality Team (PQT). The PQL ensures quality standards for product stability programs, specifications, comparability, and site and method transfers.
You will:
What We Expect of You
The ideal candidate is a self-starter with a strong background in quality management, scientific expertise, and leadership. Here’s what we’re looking for:
What You Can Expect of Us
At Amgen, we care for your professional and personal well-being. We offer a comprehensive benefits package, including health and welfare plans, financial benefits, and career development opportunities. You will also have access to:
Apply Now
For a career that challenges and inspires, join us. Keyword: Product Quality Director - Synthetics.
Application Deadline:
Amgen does not have a fixed application deadline. We will continue accepting applications until the position is filled.
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