Senior Manager Quality Operations (m/f/d)

100055 Fresenius Kabi Deutschland GmbH; Bad Homburg vor der Höhe; On-site; EUR 110,000 - 140,000; Full time

Job summary

Fresenius Kabi is seeking a Senior Manager Quality Operations (m/f/d) to drive quality and compliance across biosimilar and combination products. The role collaborates with global stakeholders and partners to support technology transfers and maintain high-quality standards in a regulated environment.

Location can be in Austria or Germany. The position requires seven+ years in a quality function, strong GMP/cGxP knowledge, and proficiency in English, with German or French as an asset.

Qualifications

• Bachelor’s, Master’s, or PhD in a technical or engineering discipline or related field or equivalent.
• Minimum seven years’ experience in a Quality function with increasing levels of responsibility biotechnology, life sciences, or pharmaceutical industry.
• Strong understanding of Quality Standards (ISO 9001, ISO 13485, ICH Q8/9/10) and cGMP for Pharmaceuticals and Combination Products.
• Experience with regulatory agencies such as the FDA, EMA, etc.
• Proven success in third-parties’ quality management.
• Professional proficiency in English; German and/or French are assets.

Responsibilities

• Maintain up-to-date knowledge of cGxP regulations and applicable standards and implement requirements into SOPs and working documents.
• Manage 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 Change Controls, Deviations, Events, CAPAs for Drug Substance/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 Management

GMP / GDP knowledge

Regulatory Affairs

Stakeholder Management

Leadership

Problem Solving

English proficiency

Biotech/Pharma knowledge

Education

Bachelor/Master/PhD in technical field

Job description

As a Senior Manager Quality Operations (m/f/d), you will play a key role in ensuring quality and compliance throughout the lifecycle of innovative biosimilar and combination products. Working closely with global stakeholders and external partners, you will drive Quality Operations activities, support technology transfers, and help maintain the highest quality standards in a highly regulated environment. This position can be based in Austria or Germany.

Your responsibilities:

• Maintain an up-to-date knowledge of cGxP regulation and applicable standards (especially in the US and EU) and implement requirements into locally applicable procedures (SOPs, Guiding Documents, Working Instructions, etc)
• 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 (qualification, approval, monitoring) of C(D)MOs, Testing Labs, Medical Devices suppliers, packagers and carriers

Your Qualifications:

• Bachelor's, Master's, or PhD degree in a technical or engineering discipline or related field or equivalent qualification
• 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 (such as ISO 9001, ISO 13485, ICH Q8, ICH Q9 & ICH 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 considered an asset
• Strong communication, leadership, problem-solving, and stakeholder management skills

Fresenius Kabi (www.fresenius-kabi.com) is a global health care company that specializes in injectable medicines, biosimilars, and technologies for infusion, transfusion, and clinical nutrition. Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients. With more than 40,000 employees worldwide, our dedicated team is united by our shared purpose: to put lifesaving medicines and technologies in the hands of people who care for patients – and to find answers to the challenges they face. We call this purpose caring for life. Follow us on LinkedIn to learn more: https://www.linkedin.com/company/freseniuskabi/