Senior Manager Quality Operations (m/f/d)

Fresenius Group; Bad Homburg vor der Höhe; A distancia; EUR 100.000 - 140.000; Jornada completa

Descripción de la vacante

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

The position can be based in Austria or Germany, with a focus on maintaining cGxP standards, managing GMP transitions, and overseeing quality controls for substances, products, and

Formación

• Experience in a Quality function within biotechnology or pharmaceutical industries.
• Knowledge of cGMP, regulatory standards and quality systems.
• Strong communication and leadership abilities in cross-functional teams.

Responsabilidades

• Maintain up-to-date knowledge of cGxP regulations and implement into local SOPs and documents.
• Oversee GMP-compliant transfer of programs from development to commercial.
• Manage GMP compliance during tech transfer of combination products.
• Lead analytical transfer activities and related GMP oversight.
• Handle change controls, deviations, events, and CAPAs for drugs and devices.
• Contribute to QM programs and ensure supplier and lab quality oversight.

Conocimientos

Quality management

Leadership

Problem solving

Stakeholder management

Regulatory knowledge

Biotech/pharma quality

Educación

Bachelor's/Master's/PhD in biotech/engineering

Descripción del empleo

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

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