CMO Quality Manager & Qualified Person (all genders)

Posted 05 Oct 2023

Darmstadt, Hessen - Germany

Req Id 268647


Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.


Your role:

You manage the Quality of Contract Manufacturing Organization and act as Qualified Person for assigned marketed products.

As Qualified Person you are responsible for batch release and batch certification for marketed product. You prepare, host and lead Health Authority Inspections, management of deviations / investigations / complaints / changes and CAPAs review and approval. Furthermore you are in charge of compliance of the marketed products in your area of responsibility towards National and International laws and guidelines such as EMA, FDA and other Health authorities' regulations as required.

As CMO Quality Manager you act as a single point of contact (internal and external) for all quality related topics associated with your assigned CMOs. You support outsourcing strategy and ensure that compliance and quality standards of the division are met. As member of cross-functional teams, you develop and monitor defined Quality KPIs of assigned CMOs and help the CMOs develop and meet our standards. Quality oversight of process and analytical technology transfers to CMOs is in your area of responsibility. You develop and control the implementation of quality/contract related processes and documents together with any internal and external party involved in manufacture and distribution operations.

Who you are:

  • Qualified Person for marketed products
  • Degree in Pharmacy, Biology or Chemistry
  • Project management skills is preferred
  • Minimum of 5 years experience in Biopharmaceutical Management in manufacturing, analytical and quality assurance in a leading biopharmaceutical company
  • CMO management experience is preferred
  • You have experience in sterile manufacturing 
  • You have experience in working in teams of an international/intercultural environment
  • You are fluent in English 

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!

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