Senior Quality Manager

3 weeks ago

Washington, Washington, D.C., United States Amgen Full time
Job Description

We are seeking a highly skilled Senior Quality Manager to join our team at Amgen. As a key member of our quality assurance team, you will play a vital role in ensuring the highest standards of quality in our clinical development programs.

Key Responsibilities:

  • Provide proactive end-to-end quality support for the development and implementation of a risk-based quality assurance strategy for clinical development programs.
  • Support the Therapeutic Area Quality Lead in ensuring quality oversight within one of four Therapeutic Areas: Oncology, Cardiovascular, Neuroscience, and Inflammation.
  • Develop and implement quality management systems to ensure compliance with regulatory requirements and industry standards.
  • Manage and support regulatory inspections, including preparation of responses to health authorities and root cause analysis.
  • Collaborate with cross-functional teams to identify and mitigate risks to critical data and processes.

Requirements:

  • Doctorate degree and 2 years of quality experience OR Master's degree and 6 years of quality experience OR Bachelor's degree and 8 years of quality experience OR Associate's degree and 10 years of quality experience OR High school diploma/GED and 12 years of quality experience.
  • Minimum of 2 years of experience directly managing people 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 where risk-based quality management and quality by design are a core responsibility.

What We Offer:

  • 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.
  • Discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
  • Stock-based long-term incentives.
  • Award-winning time-off plans and bi-annual company-wide shutdowns.
  • Flexible work models, including remote work arrangements, where possible.

About Amgen:

Amgen is a leading biotechnology company that discovers, develops, and delivers innovative human therapeutics. We are committed to improving the lives of patients worldwide by advancing medicine and science.

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