Director, Precision Medicine And Diagnostics Quality

Amgen Inc

Base: $198,507.00 - $229,864.00 usd annually; bonu...
Hybrid
Ivd regulatory compliance expertise
Risk-based quality management strategy
Gcp and ich e6 (r3) knowledge
This role provides leadership to a professional quality team supporting IVDR, GCP, and other regulatory standards for In-Vitro Diagnostics and Precision Medicine applications

Job Summary

  • This role provides leadership to a professional quality team supporting IVDR, GCP, and other regulatory standards for In-Vitro Diagnostics and Precision Medicine applications.
  • The Director is responsible for developing an end-to-end, proactive, and risk-based Quality Assurance strategy spanning from discovery through the entire lifecycle of clinical development.
  • Amgen offers a comprehensive benefits package including retirement plans, health coverage, stock-based incentives, and flexible work models to support professional growth.

Matching Summary

This role provides leadership to a professional quality team supporting IVDR, GCP, and other regulatory standards for In-Vitro Diagnostics and Precision Medicine applications.

Salary

Base: $198,507.00 - $229,864.00 USD annually; Bonus/Equity: Discretionary annual bonus and stock-based long-term incentives; Benefits: Comprehensive health, dental, vision, retirement plan, and flexible time-off

Skills & Requirements

Must-have

  • IVD regulatory compliance expertise
  • Risk-based quality management strategy
  • GCP and ICH E6 (R3) knowledge
  • Team leadership in matrixed environment
  • Third-party vendor oversight

Nice-to-have

  • AI-enabled tools proficiency
  • Veeva electronic QMS experience
  • Continuous improvement mindset
  • Strong analytical decision-making
  • Collaborative innovation culture

Key Requirements

  • Doctorate degree with 4 years experience OR Master's with 8 years OR Bachelor's with 10 years
  • Minimum 4 years direct people management or leadership experience
  • Experience with medical device development and quality management
  • Deep knowledge of IVD regulations and Global Regulations
  • Oversight of third-party vendors and suppliers

Work Rights

Not specified

Tailored Resume

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