Senior Manager, In-Vitro Diagnostics​/Precision Medicine Quality

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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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.

Let’s do this! Let’s change the world! In this remote role you will report to the Director of Precision Medicine and Diagnostics Quality within R&D Quality. This role supports the use of In-Vitro Diagnostics (IVD), including Companion Diagnostics (CDx), within Amgen’s global clinical trials. This role is responsible for supporting the implementation of a proactive and risk-based Quality strategy for IVD medical devices, including collaborations with diagnostic partners and testing laboratories.

The Precision Medicine and Diagnostic Quality strategy is focused on all aspects of research and development at Amgen, spanning from discovery through the entire lifecycle of clinical development.

• Support quality oversight of IVD medical devices used within Amgen’s precision medicine and digital medicine clinical trials.
• Provide subject matter expertise on the regulatory and quality oversight of IVDs, including CDx, Laboratory Developed Test (LDTs), assays, within the areas of precision and digital medicine.
• Support clinical trial inspections from health authorities (including inspection readiness and managing findings). This includes drug and device inspections.
• Collaborate with Amgen’s IVD and diagnostic partners to ensure quality oversight of IVDs/ assays used within Amgen drug clinical trials to ensure industry best practices and all regulations are complied with.
• Supports the IVD/ CDx team and collaborators to ensure that IVD/ CDx quality management strategies are advanced related to the evolving and complex IVD regulatory landscape, including the EU and US.
• Provide support for Quality Agreements, clinical trial protocol review, Informed Consent form reviews, IRB application review.
• Provide support for EU Clinical Performance Studies and US IDE requirement implementation.
• Understands and contributes to the collection and use of metrics (KQI, KPI leading and lagging) related to IVD and Precision Medicine for Quality Management System performance and improvement.
• Maintains up-to-date knowledge of IVD regulations and applicable guidance; monitor development of regulations and communicate impact to the business.
• Provides risk-based quality assurance and oversight for IVD/ Precision Medicine activities (e.g., auditing, deviation management and inspection management).
• Ensures that all applicable integrated procedures (e.g., acquired assets) are fit for purpose and aligned to Amgen’s standards.

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

• Doctorate degree and 2 years of quality,…