Remote Senior Manager, IVD Quality & CDx

Amgen SA; Northern (KY); Hybrid; USD 150,000 - 230,000; Full time

Benefits offered by this job

Total Rewards Plan

Stock-based incentives

Flexible work models

Job summary

Amgen seeks a Senior Manager, In-Vitro Diagnostics/ Companion Diagnostics/ Precision Medicine Quality to lead quality oversight of IVDs in global clinical trials, reporting to the Director of Precision Medicine and Diagnostics Quality within R&D Quality. This remote role supports a proactive risk-based quality strategy for IVD medical devices, including CDx and LDTs.

The role collaborates with diagnostic partners to ensure quality across Amgen’s precision medicine programs, guides inspections,

Qualifications

• Doctorate degree or equivalent in a related field with relevant experience.
• Advanced knowledge in quality and regulatory oversight for IVD/CDx.
• Experience with clinical trials and regulatory submissions.
• Experience with quality management systems and GMP/GxP environments.
• Knowledge of EU IVDR and FDA CDx requirements.

Responsibilities

• Provide quality oversight of IVDs in Amgen's precision medicine clinical trials.
• Offer SME input on regulatory oversight of IVDs including CDx and LDTs.
• Support health authority inspections and readiness.
• Collaborate with diagnostic partners to ensure quality oversight across trials.
• Advance quality management strategies for IVD/CDx with evolving regulations.
• Support quality agreements, protocol reviews, and ICF/IRB reviews.
• Contribute to EU/US regulatory compliance initiatives.
• Track and improve metrics related to IVD and Precision Medicine QMS performance.

Skills

Quality oversight

Regulatory knowledge

CDx experience

IVD knowledge

Inspection management

Analytical thinking

Cross-functional collaboration

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma

Tools

Veeva

TrackWise

LIS / Laboratory information systems

Job description

Amgen seeks a Senior Manager, In-Vitro Diagnostics/ Companion Diagnostics/ Precision Medicine Quality to lead quality oversight of IVDs in global clinical trials, reporting to the Director of Precision Medicine and Diagnostics Quality within R&D Quality. This remote role supports a proactive risk-based quality strategy for IVD medical devices, including CDx and LDTs.

The role collaborates with diagnostic partners to ensure quality across Amgen’s precision medicine programs, guides inspections,