Danaher Corporation Quality Assurance Manager (m/f/d) in Köln, Germany
Be part of something altogether life-changing!
Working at Cytiva in the Life Sciences industry means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.
The role will be part our our Cevec team. Cevec focuses on solving some of the industry’s biggest challenges in gene therapy: namely, establishing production processes that can keep up with the increasing demand for quantity and consistent quality of viral vectors.
At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40 countries, Cytiva is a place where every day is a learning opportunity – so you can grow your career and expand your skills in the long term. Your health and wellbeing are important to us and together we will not compromise on safety in the workplace or the environment.
Cytiva is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.
What you’ll do
Compliance assurance according to company wide established QMS, regulatory and customer requirements and quality objectives
Planning, execution, and coordination of internal quality management tasks
Continuous improvement of internal processes
Creation, review, and training of SOPs and other quality related procedures
Administration of training material in the electronic training management system
Change control and deviation management, monitoring of corresponding measures
Conduct internal audits, support supplier and customer audits, follow up on required corrective and preventive actions
Presenting topics in your area of expertise within internal, customer or agency audits
Actively participating in internal and customer projects as QA representative
Who you are
Degree in Biology, Biotechnology, or comparable qualification
Several years of experience in a regulated environment in biotechnology or pharmaceutical industry
Experienced in requirements and applications of QM-systems according to ISO 9001 and/or 13485
Ideally even good knowledge in current GMP regulations
Fluent in written and spoken English
High sense of responsibility and strong quality awareness
Enjoy networking and interacting with a global team
Development opportunities at Cytiva and within the Danaher Group
International corporate environment in a rapidly growing industry
When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.If you’ve ever wondered what’s within you, there’s no better time to find out.