Senior Manager, GxP Compliance Officer

🕒 July 18

🌽 Illinois – Remote

🌽 Illinois – Remote

💵 $172k - $180k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

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Fresenius Kabi USA

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

🏭 Manufacturing

📦 Logistics

Healthcare • Manufacturing • Logistics

Fresenius Kabi USA is a healthcare company that develops, manufactures, and supplies essential medicines and medical technologies for hospitals, blood centers, and healthcare providers across the United States. The company’s offerings include injectable pharmaceuticals, biopharmaceuticals, parenteral nutrition products, infusion and apheresis systems, blood collection and processing equipment, and data management solutions to support clinical and blood center operations. Fresenius Kabi USA focuses on improving access, affordability, and safety of therapies while supporting community engagement and supply chain resilience.

📋 Description

• Lead, coordinate, verify, and track global compliance activities • Evaluate investigations and changes impacting regulatory commitments • Identify and remediate plant quality and compliance risks • Support plants on strategy and compliance plans for identified gaps • Prepare manufacturing sites for US-FDA inspections • Perform mock inspections to evaluate readiness for FDA inspections • Design and deliver training to specific plants • Direct participation during US-FDA inspections and support responses to FDA-483 observations • Develop strategies to fulfill new FDA cGMP trends • Prepare global quality management documents and manage projects

🎯 Requirements

• Minimum of Bachelor’s degree required • 8+ years of experience in pharmaceutical industry and/or US-FDA • Thorough knowledge of cGMPs, cGLPs, and drug transfer processes • Professional experience in manufacturing pharmaceuticals and combination products • Ability to effectively interact with regulatory agencies and plant leadership • Strong analytical problem-solving skills • Ability to manage multiple complex situations • Ability to travel frequently, domestically and internationally • Bilingual English/Spanish preferred

🏖️ Benefits

• 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