Director, Precision Medicine and Diagnostics Quality

Company: Amgen
Location: Washington
Posted on: March 20, 2026

Job Description:

Join Amgens Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll 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 Lets do this. Lets 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 Amgens 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 Amgens In-Vitro Diagnostic use within Precision Medicine studies. Develop innovative methods for improving the quality oversight for Amgens IVD and Precision Medicine programs, including oversight of partners, suppliers, and service providers that are critical to Amgens efforts to reach the right patients at the right time and dosage. Provide quality leadership in a matrixed environment and ensure that Amgens 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 Amgens 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 Amgens 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 Amgens 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 Masters degree and 8 years of Quality Management, Quality Assurance, or other relevant experience OR Bachelors 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, well 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 representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies. Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. Sponsorship Sponsorship for this role is not guaranteed. 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.

Keywords: Amgen, Frederick , Director, Precision Medicine and Diagnostics Quality, Science, Research & Development , Washington, Maryland