Senior Manager, GxP Compliance Officer

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September 14

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Fresenius Kabi USA

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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.

1001 - 5000 employees

💊 Pharmaceuticals

🧬 Biotechnology

🤝 B2B

📋 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 plants on strategy and compliance plans for identified gaps • Prepare manufacturing sites for US-FDA inspections, including training and mock inspections • Direct participation and support during US-FDA inspections • Identify new FDA cGMP trends and develop compliance strategies • Prepare global quality management documents (e.g. SOPs) • Collaborate on strategic goals with other corporate quality functions • 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 cGMPs, ICH guidelines, and regulatory compliance • Professional experience in pharmaceutical industry involving aseptic processes, validation, and risk management • Previous experience in executing and/or managing GxP audits or inspections preferred • Strong analytical problem-solving skills and team leadership • Ability to manage multiple complex situations and travel frequently (domestically and internationally)

🏖️ 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