Senior Manager Quality Operations (m/f/d)

Fresenius SE & Co. KG aA; Bad Homburg vor der Höhe; On-site; EUR 120,000 - 180,000; Full time

Job summary

Arbeitsagentur seeks a Senior Manager Quality Operations to lead Quality Assurance activities for biosimilar and combination products. You will drive cGxP compliance, support tech transfers, and oversee external partner quality oversight in a highly regulated environment.

Requirements include 7+ years in a Quality function, strong ISO/cGMP knowledge, and experience with FDA/EMA. English proficiency mandatory; German or French is a plus.

Qualifications

• 7+ years in a Quality function with increasing responsibility in biotech, life sciences or pharma.
• Strong understanding of ISO 9001, ISO 13485, ICH Q8/9/10 and cGMP for pharma.
• Experience with FDA/EMA and other regulatory agencies.
• Proven success in managing third parties' quality programs.
• Proficient in English; German and/or French are assets.

Responsibilities

• Maintain up-to-date knowledge of cGxP and implement requirements into local SOPs and docs.
• Lead GMP-compliant transitions from development to commercial programs.
• Oversee GMP compliance during tech transfer of combination products.
• Oversee analytical transfer activities and related GMP checks.
• Manage internal and external change controls, deviations, CAPAs, and events.
• Contribute to QM programs and GMP/GDP/MDR compliance activities as appropriate.
• Provide GMP/GDP/MDR quality oversight of CDMOs, labs, suppliers, packagers, and carriers.

Skills

Quality leadership

Regulatory knowledge

Stakeholder management

Communication

Problem solving

Education

Bachelor's/Master's/PhD in technical or engineering field

Job description

About us – Senior Manager Quality Operations (m/f/d)

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