Senior Quality Management Leader

hace 4 semanas


Ciudad de México, Ciudad de México Amgen Inc. (IR) A tiempo completo

Amgen Inc. (IR) seeks a Senior Quality Management Leader to provide proactive end-to-end quality support for the development and implementation of a risk-based quality assurance strategy for clinical development programs.

About the Role

This vital position reports to the Therapeutic Area Quality Lead - Clinical & Research Quality (CRQ) and provides quality oversight for Amgen programs across all stages of products in clinical development.

Key Responsibilities

  • Provide quality oversight for Amgen programs for all stages of products in clinical development, ensuring compliance with global regulations and quality standards.
  • Develop and implement risk-based quality assurance strategies to advance quality by design principles for the full clinical trial lifecycle.
  • Conduct risk-based GCP audits, manage regulatory inspections, and provide guidance on responses to health authorities.
  • Support monthly meetings with clinical program level leaders to review quality and compliance-related risks.
  • Prepare, analyze, and identify data quality indicators, recommend corrective actions, and communicate quality metrics to key collaborators.

Requirements

  • Doctorate degree and 2 years of quality experience or Master's degree and 6 years of quality experience.
  • Minimum 2 years of experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources.
  • Preferred qualifications include 7 years or more experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry.

About Amgen

As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising 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.



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