Senior Manager, IVD Quality & Precision Medicine

Amgen; Washington (District of Columbia); Remote; USD 180,000 - 230,000; Full time

Job summary

Amgen is seeking a Senior Manager, In-Vitro Diagnostics/Companion Diagnostics/Precision Medicine Quality in a remote role reporting to the Director of Precision Medicine and Diagnostics Quality. You will lead quality oversight of IVDs in global clinical trials and work with diagnostic partners to ensure risk-based QMS.

The role requires advanced degrees with extensive regulatory exposure, experience with CDx, LDTs, and EU IVDR/FDA rules, plus strong analytical and collaborative skills.

Qualifications

• Doctorate degree with 2 years of quality, regulatory, or Companion Diagnostic experience.
• Master’s degree with 4 years of quality, regulatory, or Companion Diagnostic experience.
• Bachelor’s degree with 6 years of quality, regulatory, or Companion Diagnostic experience.
• Associate’s degree with 10 years of quality, regulatory, or Companion Diagnostic experience.
• High school diploma / GED with 12 years of quality, regulatory, or Companion Diagnostic experience.

Responsibilities

• Quality oversight of IVD medical devices in clinical trials.
• Provide regulatory and quality expertise for CDx, LDTs, assays.
• Support inspections and readiness in health authority audits.
• Collaborate with diagnostic partners to ensure regulatory compliance.
• Maintain knowledge of EU IVDR and FDA CDx rules.
• Develop and monitor quality metrics (KQI/KPI).

Skills

Quality oversight

Regulatory knowledge

Analytical thinking

Collaboration

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma

Job description

Amgen is seeking a Senior Manager, In-Vitro Diagnostics/Companion Diagnostics/Precision Medicine Quality in a remote role reporting to the Director of Precision Medicine and Diagnostics Quality. You will lead quality oversight of IVDs in global clinical trials and work with diagnostic partners to ensure risk-based QMS.

The role requires advanced degrees with extensive regulatory exposure, experience with CDx, LDTs, and EU IVDR/FDA rules, plus strong analytical and collaborative skills.