Senior Manager Quality Operations (m/f/d) (Leiter/in - Qualitätsmanagement)

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

What we offer

Drive the future of Biopharma – join #futurefresenius