Manager, Quality Assurance Auditor

Fresenius Kabi USA

Manager, Quality Assurance Auditor responsible for scheduling and leading corporate and regional compliance audits at Fresenius Kabi. Involving internal and external audits to ensure compliance and quality standards.

Posted 6/4/2026full-timeMelrose Park • Illinois • 🇺🇸 United StatesMid-LevelSenior💰 $125,000 - $135,600 per yearWebsite

About the role

Key responsibilities & impact

Responsible for scheduling and leading domestic and international Corporate and Regional Compliance Audits
Conduct internal audits of Fresenius Kabi facilities and external audits of suppliers in accordance with policies and procedures
Identify top compliance risks and communicate to management
Process complaints for timely and accurate evaluation
Backup the US Vigilance Team with submissions of Field Alert Reports (FAR) and Medical Device Reports (MDR)
Create reports for Key Process Indicators (KPI) and assist in processing complaints
Develop audit plans, conduct quality audits, prepare audit reports, and communicate findings
Drive closure of corrective and preventive actions
Assist in maintenance of the annual internal and external audit schedules

Requirements

What you’ll need

Minimum of a bachelor’s degree in sciences (Masters or higher preferred)
Minimum of 5 years of progressive, challenging QA/QC experience in pharmaceutical or biotechnology industries preferred
Certificate as a CQA Auditor, CQE, etc. is preferred
Must have at least 5+ years of extensive experience in pharmaceutical and/or biotechnology quality audits including both external and internal auditing
At least five (5) years of FDA system-based inspection is required
In-depth knowledge of Aseptic Processing, GMP and other GxP regulations
Requires a display of in-depth understanding of FDA trends, FDA and EU regulations and guidelines, and ISO 9001 standard
Proven ability to lead teams and handle project management activities without supervision
Must be flexible and able to travel domestically and/or internationally up to 50% of the time
Must demonstrate effective time management skills and the ability to adjust to and manage multiple tasks with changing priorities/assignments
Must demonstrate effective communication skills and technical writing ability

Benefits

Comp & perks

401(k) plan with company contributions
Paid vacation
Holiday and personal days
Employee assistance program
Health benefits including medical, prescription drug, dental and vision coverage

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

quality auditsinternal auditingexternal auditingcompliance auditscorrective actionspreventive actionsreport creationKPI reportingAseptic ProcessingGMP

Soft Skills

leadershipproject managementtime managementcommunicationtechnical writingflexibilityadaptabilityproblem-solvingteam collaborationmultitasking

Certifications

CQA AuditorCQE