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Senior Manager, GxP Compliance Officer
Fresenius Kabi USASr. Manager, GxP Compliance Officer responsible for compliance at Fresenius Kabi pharmaceutical facilities.
Posted 7/1/2026full-timeRemote • Illinois • 🇺🇸 United StatesSenior💰 $172,000 - $180,000 per yearWebsite
About the role
Key responsibilities & impact- Lead, coordinate, verify and track global compliance activities within the pharmaceutical division
- Evaluate Investigations and Changes impacting regulatory commitments
- Identify and remediate plant quality and compliance risks
- Support plant strategies and compliance plans for identified gaps
- Prepare manufacturing sites for US-FDA inspections
- Perform mock inspections and evaluate plants’ readiness
- Train plant staff for FDA inspection aspects and behaviors
- Participate and support during US-FDA inspections including immediate guidance
- Identify new FDA cGMP trends and develop strategies for compliance
- Prepare global quality management documents
- Collaborate with corporate quality functions on strategic goals
- Communicate findings and risks to management
Requirements
What you’ll need- Minimum of Bachelor’s degree required
- Advanced degree in chemistry, molecular biology, microbiology or engineering field is highly desirable
- 8+ years of experience in pharmaceutical industry and/or US-FDA
- Thorough knowledge of drug transfer processes and cGMPs
- Professional experience in pharmaceutical industry including technical understanding of manufacturing pharmaceuticals
- Prior experience in executing and/or managing GxP audits or inspections
- Ability to effectively interact with plant personnel and leadership
- Strong analytical problem-solving experience
- Ability to manage multiple complex situations
- Ability to travel frequently (both domestically and internationally)
- Project Management and strong communication skills required
- Bilingual English/Spanish preferred
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
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Pharmaceutical ManufacturingRegulatory Commitments EvaluationQuality Management DocumentationMock InspectionsDrug Transfer Processes
Soft Skills
Strong CommunicationInterpersonal InteractionComplex Situation Management