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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.

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.

The role will be part of our Cevec team. Cevec is a leading provider of high-performance cell technology for the manufacturing of advanced bio-therapeutics from R&D to manufacturing scale. The company’s product portfolio comprises various platform technologies for gene therapy vectors, vector vaccines and complex recombinant proteins. The Cevec team, with around 60 employees, is based in Cologne with its laboratories and offices.

What you’ll do

  • P lanning, execution, and coordination of a variety of (internal) quality management task within the established QMS

  • Take care of compliance assurance according to company wide established QM system, regulatory requirements, and quality objectives

  • Continuous improvement of internal processes using tools as Kaizen, LEAN

  • Creation, review and training of SOPs and other quality related documents or procedures

  • Administration of e.g., documents in the electronic DMS system and support the administration and maintenance of our laboratory monitoring system

  • Change control and deviation management, follow up on required corrective and preventive actions, monitoring of corresponding measures

  • Collaborate with international multidisciplinary teams within the organization

  • Conduct internal audits, support supplier and customer audits

  • Actively participating in internal and customer development projects as QA representative

Who you are

  • Degree in Biology, Biotechnology, or comparable qualification

  • Preferably Quality Management experience according to e.g. ISO 9001 or ISO 13485

  • Ideally even good knowledge in current GMP regulations

  • Knowledge of laboratory or cell culture work is a plus

  • Fluent in written and spoken English

  • High sense of responsibility and strong quality awareness

  • Enjoy working in a mid-sized team and interacting with the global Cytiva team

Benefits

  • Attractive salary

  • Development opportunities at Cytiva and within the Danaher Group

  • International corporate environment in a rapidly growing industry

#LI-AC3

#LI-hybrid

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.

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