Senior QA Manager

Amgen

. Program manage remediation of assigned critical external mechanical device suppliers .

Posted 9/29/2026full-timeRemote • United StatesSenior💰 $132,037 - $178,639 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing supplier quality and compliance within the medical device, pharma, or biotech sectors, while fostering a culture of continuous improvement and operational excellence. Proven ability to lead cross-functional teams and drive impactful initiatives in a global environment.

Highest-signal resume keywords

Supplier Quality ManagementQuality Systems KnowledgeLeadership ExperienceRegulatory ComplianceCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality SystemsRisk ManagementBatch ReleaseSupplier ManagementDevice Regulations

Soft Skills

LeadershipCommunicationProblem-Solving

Industry Keywords

Medical DevicePharmaBiotechGlobal OperationsContinuous Improvement

About the role

Key responsibilities & impact

Program manage remediation of assigned critical external mechanical device suppliers
Lead a team of quality professionals overseeing external mechanical device suppliers
Ensure compliance with scientific, regulatory, and quality standards across global operations
Collaborate cross-functionally with teams in External Supply, Process Development, and Combination Product Quality
Drive change, ensure product quality, and create a diverse and inclusive environment
Monitor quality systems and performance of external device suppliers
Define and enforce quality requirements
Manage supplier quality KPIs and risk escalations
Manage and develop assigned team members
Lead impactful cross-functional initiatives
Foster a culture of continuous improvement and operational excellence

Requirements

What you’ll need

Doctorate degree and 2 years of experience, OR Master’s degree and 4 years of experience, OR Bachelor’s degree and 6 years of experience, OR Associate’s degree and 10 years of experience, OR High school diploma / GED and 12 years of experience
Degree in Biology, Engineering, Pharmaceutics, Biotechnology, or Physics preferred
10+ years in Medical Device/pharma/biotech sectors preferred
Extensive knowledge of quality systems (batch release, complaints, risk management)
Knowledge of global supplier management and device regulations
Strong leadership, communication, and problem-solving skills
Experience managing global teams, including during change
Travel up to 25%, domestic and international
Sponsorship for this role is not guaranteed

Benefits

Comp & perks

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
Group medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
A discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible
Financial plans with opportunities to save towards retirement or other goals
Career development opportunities
Health and welfare plans for staff and eligible dependents