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 responsibilitiesMaintain 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 commercialManage GMP compliance during Tech Transfer of manufacturing activities of Combination ProductManage GMP compliance during Analytical Transfer activitiesManage internal and external Change Controls, Deviations, Events, CAPAs, etc., related to Drug Substance, Drug Product and Combination ProductsContribute to QM programs and GMP/GDP/MDR compliance activities as appropriateManage GMP/GDP/MDR quality oversight (qualification, approval, monitoring) of C(D)MOs, Testing Labs, Medical Devices suppliers, packagers and carriersYour QualificationsBachelor's, Master's, or PhD degree in a technical or engineering discipline or related field or equivalent qualificationMinimum seven years' experience in a Quality function with increasing levels of responsibility biotechnology, life sciences, or pharmaceutical industryStrong 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 ProductsStrong understanding of GMPs and best quality practices with regards to biotech manufacturing processesExperience with regulatory agencies such as the FDA, EMA, etc.Proven success in third-parties' quality managementProfessional proficiency in English, both written and spoken; German and/or French are considered an assetStrong communication, leadership, problem-solving, and stakeholder management skills #J-18808-Ljbffr
Senior Manager Quality Operations (m/f/d) in Feldatal Arbeitgeber: Arbeitsagentur
Unsere moderne Steuerkanzlei in Merseburg bietet Ihnen die Möglichkeit, Ihr Wissen und Talent in einem freundlichen und offenen Team einzubringen. Wir legen großen Wert auf ein angenehmes Betriebsklima, flexible Arbeitszeiten und vielfältige Weiterbildungsmöglichkeiten, um Ihre berufliche Entwicklung zu fördern. Bei uns sind Sie nicht nur ein Mitarbeiter, sondern ein geschätztes Mitglied, das aktiv zum Erfolg unserer Kanzlei beiträgt.
