Director, Precision Medicine and Diagnostics Quality

Career Category

Quality

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).

• Ensure that all applicable integrated procedures (e.g., acquired assets) are fit for purpose and aligned to Amgen’s standards.   

• Oversee the management of IVD-related QMS elements related to business procedures including the development and execution of the process and audit program, and the support of Inspections by Health Authorities or notified bodies. 

• Develop and lead a global team of quality professionals to support advancement of Amgen’s Precision Medicine pipeline and to continuously improve processes.

• The role can be Flex-worker/hybrid or fully remote.

WHAT WE EXPECT OF YOU 

We are all different, yet we all use our unique contributions to serve patients. The individual we seek has technological literacy and leadership skills, and has these qualifications:  

Basic Qualifications:

• Doctorate degree and 4 years of Quality Management, Quality Assurance, or other relevant experience OR

• Master’s degree and 8 years of Quality Management, Quality Assurance, or other relevant experience OR

• Bachelor’s degree and 10 years of Quality Management, Quality Assurance, or other relevant experience

In addition to meeting at least one of the above requirements, you must have at least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

• 7 years of managerial experience directly leading people in a multi-tiered organization and/or leadership experience leading teams, projects, programs or directing the allocation of resources. 

• 7 years or more experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry developing and implementing risk-based quality oversight/ management, and experience with medical device development and quality management.   

• Oversight and implementation of Quality Management Systems, including use of electronic QMS such as Veeva.  

• Proficiency in the practical application of AI-enabled tools to enhance day-to-day productivity and business outcomes, including the ability to synthesize information, generate insights, streamline workflows, and apply appropriate judgment.

• Deep knowledge of QMS requirements related to IVD, medical device regulations, and Precision Medicine; implementation of technology to improve knowledge management across a diverse R&D environment.

• Thorough understanding of Biotech/pharmaceutical Research activities and Global Regulations. 

• Experience with compliance to all GxP requirements including the oversight of third-party vendors, suppliers, and partners. 

• Ability to transform business and stakeholder feedback into clear, efficient processes using a straightforward language and format. 

• Strong analytical, critical-thinking, and decision-making abilities, including development and implementation of Analytics methods and technology in order to enable signal detection and quality improvement.  

• People leadership and managerial expertise, and an ability to build a high performing team. 

• Excellent verbal and written communication skills, including strong business writing abilities and active listening. 

• Capability to understand and articulate technical concepts and literature in spoken and written English. 

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.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts

• A discretionary annual bonus program, or for field sales re