Senior Manager, In-Vitro Diagnostics, Precision Medicine Quality

Amgen

. Support quality oversight of IVD medical devices used within Amgen’s precision medicine and digital medicine clinical trials .

Posted 10/8/2026full-timeRemote • United StatesSenior💰 $132,037 - $178,639 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory and quality oversight of In-Vitro Diagnostics (IVD) and Companion Diagnostics (CDx), with a strong understanding of global regulations and quality management systems. Capable of supporting clinical trials and ensuring compliance through effective collaboration and innovative quality strategies.

Highest-signal resume keywords

IVD Quality OversightRegulatory ComplianceCompanion Diagnostics ExperienceQuality Management Systems (QMS)Clinical Trial Support

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality AssuranceRegulatory OversightIVD Medical Device DevelopmentDesign ControlsAnalytics Method DevelopmentRisk-Based Quality AssuranceDeviation ManagementInspection ManagementKQI/KPI Metrics CollectionQuality by Design Principles

Soft Skills

Analytical ThinkingCritical ThinkingDecision-MakingCollaborative WorkInnovative Thinking

Tools & Technologies

Electronic QMSVeevaTrackWise

Certifications & Qualifications

CLIA CertificationISO 15189 Certification

Industry Keywords

In-Vitro Diagnostics (IVD)Companion Diagnostics (CDx)EU IVDRFDA CDx Final RuleGxP RequirementsBiomarker TestingClinical Performance Studies

About the role

Key responsibilities & impact

Support quality oversight of IVD medical devices used within Amgen’s precision medicine and digital medicine clinical trials
Provide subject matter expertise on regulatory and quality oversight of IVDs, including CDx, LDTs and assays
Support clinical trial inspections from health authorities, including inspection readiness and management of findings
Collaborate with IVD and diagnostic partners to ensure quality oversight and regulatory compliance
Advance IVD/CDx quality management strategies in response to the evolving EU and US regulatory landscape
Support Quality Agreements, clinical trial protocol reviews, informed consent form reviews and IRB application reviews
Support EU Clinical Performance Studies and US IDE requirement implementation
Contribute to collection and use of KQI/KPI metrics for Quality Management System performance and improvement
Maintain current knowledge of IVD regulations and guidance; monitor regulatory developments and communicate business impact
Provide risk-based quality assurance and oversight, including auditing, deviation management and inspection management
Ensure integrated procedures are fit for purpose and aligned with Amgen standards
Report to the Director of Precision Medicine and Diagnostics Quality within R&D Quality

Requirements

What you’ll need

Doctorate degree and 2 years of quality, regulatory or Companion Diagnostic experience OR Master’s degree and 4 years of quality, regulatory, or Companion Diagnostic experience OR Bachelor’s degree and 6 years of quality, regulatory, or Companion Diagnostic experience OR Associate’s degree and 10 years of quality, regulatory, or Companion Diagnostic experience OR High school diploma / GED and 12 years of quality, regulatory, or Companion Diagnostic experience
Experience within the pharmaceutical/ biotech, medical device, and/or biomarker industry working with In-Vitro Diagnostics (IVD) and preferably Companion Diagnostic (CDx) devices
Experience at EU clinical trial sites, either as a site monitor or study management
Experience working with Companion Diagnostics/assay development for the pharmaceutical industry/CLIA cert and/or ISO 15189 cert labs/biomarker testing
Experience working in a quality management system role or relevant clinical research environment with quality oversight
Working knowledge of IVD medical device development, including design controls
Knowledge of global regulations related to companion diagnostics and assay development, including EU IVDR and FDA CDx Final Rule
Understanding of Precision Medicine and applicable global regulations
Understanding of EU IVD performance studies under EU IVD Regulation
Understanding of Quality Management Systems (QMS), including electronic QMS such as Veeva or TrackWise
Experience with GxP requirements and oversight of third-party vendors, suppliers, and partners
Ability to incorporate feedback into clear, efficient processes
Strong analytical, critical-thinking, and decision-making abilities
Experience developing and implementing analytics methods and technology for signal detection and quality improvement
Innovative thinking, including application of quality by design principles
Ability to work collaboratively and support a high-performing team

Benefits

Comp & perks

Comprehensive employee benefits package
Retirement and Savings Plan with generous company contributions
Group medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible
Career development opportunities
Financial plans with opportunities to save towards retirement or other goals
Work/life balance