Global Quality Auditor (m/f/d)

Established in 2014, our department is essential in maintaining Fresenius Kabi's commitment to the highest standards of quality and regulatory compliance. We are focused on performing high-quality audit with independence, integrity, objectivity, and professionalism to enable certifications and drive continuous improvement within the Quality Management System (QMS) through respectful and collaborative partnerships across the organization. Our vision is to cultivate a culture of quality, empowering teams to surpass expectations and contribute to the enhancement of patient care globally. 

Your assignments 

• Lead and execute global internal quality audits across diverse operations, including manufacturing, R&D, sales, and marketing. 

• Ensure compliance with international standards and regulatory requirements such as EU-GMP, FDA cGMP, ISO 13485, and internal company guidelines. 

• Identify, evaluate, and communicate compliance risks using a risk-based approach, delivering precise and timely audit reports. 

• Analyze audit trends and regulatory findings to propose improvements to audit processes and content. 

• Conduct peer reviews, provide training, and support team skill development to enhance audit effectiveness. 

• Contribute to the enhancement of the Global Quality System through active participation in targeted projects. 

• Travel frequently, up to 50%, to perform audits globally, with flexibility for short-notice assignments. 

Your profile 

• Hold a Diploma or Master’s degree in natural sciences (e.g., Chemistry, Pharmacy, Engineering) or demonstrate equivalent expertise through extensive professional experience. 

• Minimum 7 years of operational experience in healthcare industries, focusing on GxP and/or Medical Device regulations, with expertise in EU GMP and FDA regulatory compliance. 

• Strong knowledge of pharmaceutical aseptic/sterile manufacturing and medical device facility operations, including ISO 13485 and relevant Medical Device Directives. 

• Proven ability to communicate effectively, prepare concise reports, and collaborate across teams in a global setting. 

• Fluency in English, with additional language skills considered an asset for international collaborations. 

• Possess exceptional decision-making skills, with a risk-based approach to problem-solving and the ability to perform under pressure. 

• Willingness to travel internationally up to 50% of the time, including short-notice assignments and occasional weekend schedules.