Head of Global Quality Management & Regulatory Affairs Bioprocess (m/w/d)

Would you like to work for a company who has made it its mission to make a contribution to improving human living conditions? With around 5,000 employees worldwide Eppendorf is a leading Life Sciences company. We develop and distribute devices, consumables and services for use in laboratories worldwide. Our daily work is characterized by our principle: Collaborate on new ideas. You would like to take responsibility and help to make a difference in an experienced international company? Exciting tasks combined with a positive and affirmative working environment await you at Eppendorf. You are also motivated by technical challenges? Then apply now!

Your challenges

• The Head of Global Quality Management and Regulatory Affairs Bioprocess is responsible for the strategic and operational Bioprocess Quality Management System and regulatory compliance, including:
• Ensure and further develop compliance regarding ISO 9001, 13485, GMP and potentially US FDA 21 CFR Part 820 of the company in the QM matrix
• Driving the development of the global Bioprocess Quality and RA strategy as well as targets
• Establishment and development of the Customer/Case Management process
• Managing the Bioprocess Quality Manager and Regulatory Affairs Manager in the respective area of responsibility including direct and indirect responsibility for employees which will operate within a matrix environment
• Leading, developing the global Bioprocess quality team incl. all related budget responsibilities

• Quality Management
• Responsible for implementing and maintaining the effectiveness of the quality management system according to ISO 9001, 13485, GMP and US FDA 21 CFR Part 820 Quality Systems Regulation
• Being the representative of the Bioprocess Quality Department towards external Authority inspections and client audits (Management Representative acc. to 13485)
• Proactively provides leadership in Bioprocess Quality System definition and deployment with focus on prevention, continuous improvement programs, and customer satisfaction
• Provide quality and process related training
• Conduct internal functional/organizational Audits as well to interfaces like Sales & Service organization, Competence Center and supplier, distributor
• Establish and monitor KPI performance including data collection and providing reports to the management

• Complaint Management
• Establishment and development of the Customer/Case Management process
• As Complaint Management process owner monitor the uniformity of the complaint management process and analyze the effectiveness and identify improvement opportunites
• Prepare reporting for internal review meetings (create reports, pattern search, trend identification)
• Work closely with the Product Management, Production and Service teams to prioritize and answer the most important questions where our product and service performance will have impact to our customers
• Support in the design and implementation of the company-wide data management strategy in Customer Complaint Management

Your expertise

• Deep knowledge in Q-Systems ISO 9001, 13485, GMP, beneficial experiences with UD FDA 21 CFR Part 820 Quality Systems Regulation
• At least 10 years of experience in the Life Science or Medical Device industry
• Many years of experience in the design and implementation of QM systems und business processes
• Degree in engineering in natural sciences or comparable technical education
• Fluent in German and English
• Life science/ Medical device Industry experience
• Strong interpersonal skills, ability to collaborate and network effectively

Please note that we can only consider applications that are submitted online via our application management tool.