Quality Manager Gene Therapy (m/w/d)

DAS UNTERNEHMEN

For an innovative biotech company in southern Germany we're looking for a manager quality/ CMC (m/f/d) in the field of gene therapy. The position can be either be a full time or a part time one. 

 

IHRE AUFGABEN

• Development and maintenance of a Quality Management System together with external experts
• Prepare, execute and follow up internal, external and supplier audits
• Preparation and development of processes and description thereof in SOPs
• Support acquisition of a manufacturing license for therapeutic products
• Lead or participate in quality management improvement projects
• Author and review of quality related documents
• Be the main contact person for colleagues from other departments encountering quality related questions
• Plan and execute training arrangements for colleagues and new employees with regard to the quality management system
• Support or lead on CMC related questions and documentation

IHR PROFIL

• M.Sc. or Ph.D. in molecular biology, virology, biotechnology, pharmacology or related field
• Multiannual work experience in quality management in industrial settings, preferably in biopharmaceutical industry or at a CDMO
• Proficient knowledge on national and international standing regulations (GMP
• Experience in planning and execution of internal, external and/or supplier audits
• Basic knowledge about largescale AAV manufacturing
• Able to work under minimal supervision, be teamoriented and collaborative, able to multitask and manage different projects
• Outstanding communication skills
• Language proficiency (English fluent in spoken and written)
• Knowledge of AAV molecular biology would be a nice to have
• In depth understanding of AAV manufacture in industrial settings as well as relevant CMC technologies and documentation thereof would be a nice to have

BENEFITS

• Position based in a very attractice area of southern germany
• multicultural teams and an open corporate culture
• an inspiring working atmosphere as fertile ground for your further development
• an interesting chance in an exciting industry