Senior Manager Quality Operations (m/f/d)

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

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