Senior Quality Operations Leader - Biotech (EU)

Fresenius Kabi USA; Graz; On-site; EUR 110,000 - 150,000; Full time

Job summary

Fresenius Kabi USA seeks a Senior Manager Quality Operations to ensure quality and regulatory compliance across biosimilar and combination products. The role collaborates with global stakeholders, drives QO activities, and supports technology transfers in a highly regulated setting.

Based in Austria or Germany, the position requires strong GMP/GxP expertise, extensive experience in quality management, and excellent English communication.

Qualifications

• Bachelor’s, Master’s, or PhD in a technical or engineering discipline or related field
• Minimum seven years’ experience in a Quality function with increasing levels of responsibility biotechnology, life sciences, or pharmaceutical industry
• Strong understanding and interpretation of Quality Standards (ISO 9001, ISO 13485, ICH Q8/Q9/Q10), cGMP requirements for Pharmaceuticals and Combination Products, including Biologic Products
• Strong understanding of GMPs and best quality practices with regards to biotech manufacturing processes
• Experience with regulatory agencies such as the FDA, EMA, etc.
• Proven success in third-parties’ quality management
• Professional proficiency in English, both written and spoken; German and/or French are assets
• Strong communication, leadership, problem-solving, and stakeholder management skills

Responsibilities

• Maintain up-to-date knowledge of cGxP regulation and applicable standards and implement requirements into SOPs, Guiding Documents, and Working Instructions
• Manage a GMP compliant transition of Programs from development to commercial
• Manage GMP compliance during Tech Transfer of manufacturing activities of Combination Product
• Manage GMP compliance during Analytical Transfer activities
• Manage internal and external Change Controls, Deviations, Events, CAPAs, etc., related to Drug Substance, Drug Product and Combination Products
• Contribute to QM programs and GMP/GDP/MDR compliance activities as appropriate
• Manage GMP/GDP/MDR quality oversight of CDMOs, Testing Labs, Medical Devices suppliers, packagers and carriers

Skills

Quality governance

Regulatory affairs

GMP knowledge

Leadership

Stakeholder management

Problem solving

Biotech/pharma

English proficiency

Quality standards

Education

Bachelor/Master/PhD in technical field

Job description

Fresenius Kabi USA seeks a Senior Manager Quality Operations to ensure quality and regulatory compliance across biosimilar and combination products. The role collaborates with global stakeholders, drives QO activities, and supports technology transfers in a highly regulated setting.

Based in Austria or Germany, the position requires strong GMP/GxP expertise, extensive experience in quality management, and excellent English communication.