Director, Precision Medicine and Diagnostics Quality

Career Category

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

Director, Precision Medicine and Diagnostics Quality

Let’s do this.  Let’s change the world. In this vital role you will report to the Executive Director, Precision Medicine/Dx and R&D Supplier Quality. The Director, Precision Medicine/Dx provides leadership to a professional quality team who support IVDR, ICH E6 (R3), GCP, and other relevant regulatory requirements and standards related to In-Vitro Diagnostics (IVD), including Digital Diagnostics, Companion Diagnostics (CDx), and Precision Medicine applications in clinical development.  This role is responsible for the development and implementation of an end to end, proactive and risk-based Quality Assurance strategy for Precision Medicine and Diagnostics, including third-party collaborations.

The Precision Medicine/Dx Quality strategy is focused on all aspects of research and development at Amgen, spanning from discovery through the entire lifecycle of clinical development.  This strategy will ensure that all Amgen’s business procedures meet internal and external quality standards, and that they are managed for optimum efficiency and effectiveness.  The Precision Medicine/Dx Quality strategy also includes development and management of fit-for-purpose standards (e.g. SOPs and quality agreements).  In addition, the strategy will drive continuous improvement using quality by design and risk-based quality management principles, and outputs from the Quality Management System including analytics showing quality trends and potential continuous improvement opportunities.   

RESPONSIBILITIES  

• Develop collaborative partnerships with Research and Development (R&D) Leadership to define the state of quality and potential areas of quality risk exposure for Amgen’s In-Vitro Diagnostic use within Precision Medicine studies. 

• Develop innovative methods for improving the quality oversight for Amgen’s IVD and Precision Medicine programs, including oversight of partners, suppliers, and service providers that are critical to Amgen’s efforts to reach the right patients at the right time and dosage. 

• Provide quality leadership in a matrixed environment and ensure that Amgen’s R&D efforts, including partnerships and third parties, are aligned to industry best practices and all regulations. 

• Develop and implement IVD quality management strategies (including risk-based regulatory approaches) that ensure compliance to an evolving and complex IVD regulatory landscape, particularly in the EU and US. 

• Partner with leadership teams and key stakeholders to develop/ monitor metrics (KQI, KPI leading and lagging) for critical to quality IVD and Precision Medicine processes that aim to identify risks and areas needing improvement at key oversight forums (e.g. management reviews). 

• Coordinate and collaborate with clinical trial teams to ensure that all respective critical to quality components are incorporated into clinical trial design, execution and support of regulatory filings.     

• Maintain up-to-date knowledge of IVD regulations and applicable guidance, including but not limited to: Monitor developing enforcement of new regulations and communicate impact to the business; Exert influence on national competent authorities/ health authorities’ interpretation/ approach to IVD implementation for complex diagnostic test scenarios/case studies; Develop and model efficient, risk-based approaches to IVDR compliance throughout Amgen’s portfolio;

• Provide risk-based quality assurance and oversight for IVD/ Precision Medicine activities (e.g., auditing, deviation management and inspection management).