Senior IVD Quality & CDx Leader - Remote

BioSpace; Washington (District of Columbia); À distance; USD 140 000 - 190 000; Plein temps

Résumé du poste

Amgen is seeking a Senior Manager for In-Vitro Diagnostics/ Companion Diagnostics/ Precision Medicine Quality. In this remote role, you will support a proactive quality strategy for IVD devices within global clinical trials, partnering with diagnostic labs and vendors.

The role covers quality oversight, regulatory compliance, and collaboration across EU and US, with a focus on CDx, LDTs, and precision medicine.

Qualifications

• Doctorate with 2+ years of quality, regulatory or Companion Diagnostic experience, or equivalent.
• Masters with 4+ years in quality, regulatory, or CDx experience.
• Bachelor's with 6+ years in quality, regulatory, or CDx experience.
• Associates with 10 years in quality, regulatory, or CDx experience.
• High school diploma with 12 years in quality, regulatory, or CDx experience.

Responsabilités

• Provide quality oversight of IVDs in precision medicine trials.
• Offer SME input on regulatory oversight of IVDs incl. CDx, LDTs, assays.
• Support inspections from health authorities (inspections readiness and findings).
• Collaborate with IVD partners to ensure quality across trials.

Connaissances

Quality management

Regulatory knowledge

Analytics

Critical thinking

Collaboration

Formation

Doctorate degree

Masters degree

Bachelor's degree

Associates degree

High school diploma

Outils

Veeva

TrackWise

Description du poste

Amgen is seeking a Senior Manager for In-Vitro Diagnostics/ Companion Diagnostics/ Precision Medicine Quality. In this remote role, you will support a proactive quality strategy for IVD devices within global clinical trials, partnering with diagnostic labs and vendors.

The role covers quality oversight, regulatory compliance, and collaboration across EU and US, with a focus on CDx, LDTs, and precision medicine.