Senior QA Manager – External Supply Quality, Supplier Quality Management

Amgen

QA Senior Manager overseeing quality of global suppliers at Amgen. Responsible for ensuring compliance and continuous improvement across supplier relationships and quality oversight.

Posted 5/5/2026full-timeRemote • California, Massachusetts, North Carolina, Rhode Island • 🇺🇸 United StatesSenior💰 $144,021 - $194,852 per yearWebsite

About the role

Key responsibilities & impact

Serve as the quality lead and subject matter expert for critical global suppliers of GMP raw materials
Own the end-to-end quality oversight of assigned suppliers—from onboarding through ongoing performance monitoring to disengagement
Act as the primary quality contact for internal stakeholders, supporting issue resolution, supplier strategy, and cross-functional initiatives
Perform proactive quality management of suppliers, ensuring compliance with global regulatory standards
Review and approve quality documentation
Participate in and/or lead supplier audits and collaborate with internal and external partners
Prepare Amgen sites and suppliers for audits and inspections
Identify and mitigate risks at the supplier and/or escalate to management
Drive audit commitments to completion.
Act as a key quality partner to External Supply, Manufacturing, Supply Chain, Material Sciences, Engineering Technical Authority (ETA), Process Development and other internal functions.
Take the lead and/or participate in cross-functional initiatives and continuous improvement projects.

Requirements

What you’ll need

High school diploma / GED and 12 years of Quality experience OR Associate’s degree and 10 years of Quality experience OR Bachelor’s degree and 8 years of Quality experience OR Master’s degree and 6 years of Quality experience OR Doctorate degree and 2 years of Quality experience
minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.
Educational background in Life Sciences
Strong technical knowledge and experience within operations in the pharmaceutical or GMP-regulated industry
Relevant work experience within Drug Substance and Drug Product operations
ideally with single use systems and platforms
5+ years of experience overseeing quality of suppliers
Robust problem-solving and root-cause analysis experience
Strong continuous improvement mentality
Strong compliance, quality, and regulatory knowledge with critical thinking, inquisitive with an end-to-end mentality
Strong report writing and presentation skills
Experience driving decision-making by using DAI principles
Understanding of industry requirements/expectations of a QMS
Savvy with data and Artificial Intelligence tools
Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes).

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, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible.

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

quality managementGMP complianceroot-cause analysiscontinuous improvementreport writingpresentation skillsDAI principlesQMS understandingDrug Substance operationsDrug Product operations

Soft Skills

problem-solvingcritical thinkingleadershipinquisitive mindsetcommunicationcollaborationrisk managementdecision-makingcross-functional teamworkperformance monitoring