Senior Quality Assurance Manager

Amgen

Quality Assurance Senior Manager responsible for quality oversight of secondary packaging suppliers at Amgen. Collaborating with external supply and various teams to ensure product quality and compliance.

Posted 5/5/2026full-timeRemote • Ohio • 🇺🇸 United StatesSenior💰 $132,037 - $178,638 per yearWebsite

About the role

Key responsibilities & impact

Ensure appropriate quality oversight of suppliers in line with global regulations, defines quality requirements for suppliers and monitors performance
Monitors and assigns quality status and, if required, determines remediation actions and additional oversight needed, including technical site visits
Maintains key quality performance indicators for suppliers of responsibility
Review and approval of quality records such as; Quality Agreements, supplier investigations, deviations, supplier change notifications, change controls, CAPAs, and CAPA-EV’s
Manage supplier audits to completion
Act as point of contact for Amgen sites to resolve concerns and support projects regarding secondary packaging materials and suppliers
Represent Amgen at product-specific regulatory inspections and/or during Notified Body audits of supplier site
Identify and mitigate risks at supplier site and raise to management as appropriate
Onboard and offboard suppliers and/or manufacturing location as needed
Lead departmental improvement projects regarding continuous improvement and automation

Requirements

What you’ll need

Doctorate degree and 2 years of Quality and Compliance experience OR Master’s degree and 4 years of Quality and Compliance experience OR Bachelor’s degree and 6 years of Quality and Compliance experience OR Associate’s degree and 10 years of Quality and Compliance experience OR High school diploma / GED and 12 years of Quality and Compliance experience
Educational background in Life Sciences
Strong technical knowledge and experience within operations in the pharmaceutical or GMP-regulated industry
Relevant work experience within Drug Product and Finished Drug Product operations
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 communication skills with proficiency in the English language and collaborative cross-functionally behavior
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.

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Applicant Tracking System Keywords

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Hard Skills & Tools

Quality and Compliance experienceQuality performance indicatorsSupplier auditsQuality AgreementsCAPAsRoot-cause analysisContinuous improvementDAI principlesQMSManufacturing/testing processes

Soft Skills

Problem-solvingCritical thinkingCommunication skillsCollaborative behaviorReport writingPresentation skillsInquisitive mindsetEnd-to-end mentalityLeadershipOrganizational skills