Senior Manager, GxP Compliance Officer

🔥 8 hours ago

🌽 Illinois – Remote

🌽 Illinois – Remote

💵 $172k - $180k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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Fresenius Kabi USA

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

💊 Pharmaceuticals

🧬 Biotechnology

🤝 B2B

Pharmaceuticals • Biotechnology • B2B

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 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

• 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

• 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