Remote Senior Manager, IVD & Precision Medicine Quality

Regulatory Jobs; United States; Remote; USD 132,000 - 179,000; Full time

Job summary

Amgen is seeking a Senior Manager for In-Vitro Diagnostics/ Companion Diagnostics/ Precision Medicine Quality to lead quality oversight for IVDs in global clinical trials. The role focuses on risk-based quality strategies, collaboration with diagnostic partners, and ensuring regulatory compliance across EU and US frameworks.

The position reports to the Director of Precision Medicine and Diagnostics Quality within R&D Quality and is described as a remote role with a focus on advancing CDx and

Qualifications

• Doctorate with 2+ years of quality/regulatory or CDx experience
• Master’s with 4+ years in quality/regulatory or CDx
• Bachelor’s with 6+ years in quality/regulatory or CDx
• Associate’s with 10+ years in quality/regulatory or CDx
• High school with 12+ years in quality/regulatory or CDx

Responsibilities

• Provide quality oversight for IVDs used in precision medicine trials.
• Offer regulatory oversight for IVDs and companion diagnostics (CDx)
• Support inspections by health authorities and inspection readiness
• Collaborate with IVD partners to ensure QMS alignment with regulations
• Contribute to quality agreements, protocol reviews, and consent forms
• Monitor metrics (KQI/KPI) and drive quality improvements across studies

Skills

Analytical thinking

Regulatory knowledge

Quality assurance

Cross-functional collaboration

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma

Tools

Veeva

TrackWise

Job description

Amgen is seeking a Senior Manager for In-Vitro Diagnostics/ Companion Diagnostics/ Precision Medicine Quality to lead quality oversight for IVDs in global clinical trials. The role focuses on risk-based quality strategies, collaboration with diagnostic partners, and ensuring regulatory compliance across EU and US frameworks.

The position reports to the Director of Precision Medicine and Diagnostics Quality within R&D Quality and is described as a remote role with a focus on advancing CDx and