Quality Manager (f/m/d) 241677

The Berlin Center for Epidemiology and Health Research (ZEG Berlin) is a research organization in the heart of Berlin and at the forefront of pharmacoepidemiology research, specializing in the early detection and quantification of safety risks associated with the use of therapeutic, preventative or diagnostic drugs.

As a Quality Manager your responsibilities will include:

• Assisting and supporting autonomously the continuous improvement processes (CAPA management), including documentation
• Managing controlled documents and corresponding overviews
• Collaborate and executing quality management processes and guidelines to ensure quality standards are maintained and compliant with regulatory requirements and other applicable regulations, e.g. current Good Practices (GxP)
• Supporting and independent conducting of internal and external audits
• Assisting with network definitions and archiving processes
• Conducting and attending regular quality meetings and internal trainings
• Supporting the overseeing of internal staff documents on quality-related activities
• Providing support regarding (study specific) quality management questions and tasks

Career Level - IC2

Responsibilities

• Degree in Life Sciences or other relevant discipline
• Preferably several years of quality operations experience in a regulated environment (pharmaceutical, biotechnology, medical device or other)
• Knowledge in working with Quality Management Systems, including GxP regulations, practices and trends pertaining to epidemiological and clinical studies • Full working proficiency in English and German speaking and writing
• Ability to work mainly independently but also as part of a team with a flexible and positive attitude
• Strong motivation and attention to detail, critical thinking ability
• Proficient computer knowledge and being confident in using the Microsoft Office applications (Outlook, Word, Excel, PowerPoint)
• Effective and systematic communication and presentation skills, including the ability to communicate quality issues to non-quality staff in a clear and concise manner.

A career at Oracle is defined by you. We give you the freedom-and the skills-to write your own success story. Whatever avenue you go down, you'll gain priceless learning experiences and be supported to do your best work. At Oracle, we don't just respect differences-we celebrate them. We believe that innovation starts with inclusion and to create the future we need people with diverse backgrounds, perspectives, and abilities. That's why we're committed to creating a workplace where all kinds of people can do their best work. It's when everyone's voice is heard and valued that we're inspired to go beyond what's been done before. We expressly encourage disabled candidates to apply for this position. Please therefore feel free to voluntarily inform us in your application about any severe disability (degree of disability of at least 50%) or any equal status (degree of disability of at least 30% together with official decision on equality) in accordance with the German SGB IX.