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Director, Precision Medicine and Diagnostics Quality

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Amgen

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Location:
United States

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

198507.00 - 229864.00 USD / Year
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Job Description:

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.

Job Responsibility:

  • 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
  • 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

Requirements:

  • Doctorate degree and 4 years of Quality Management, Quality Assurance, or other relevant experience
  • Master’s degree and 8 years of Quality Management, Quality Assurance, or other relevant experience
  • Bachelor’s degree and 10 years of Quality Management, Quality Assurance, or other relevant experience
  • At least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources

Nice to have:

  • 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 we offer:
  • 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
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models where possible

Additional Information:

Job Posted:
March 21, 2026

Employment Type:
Fulltime
Work Type:
Remote work
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