Manager Quality Control

Manager Quality Control

Bavarian Nordic

Munich, Germany

You will be a part of our global QC team and will lead a dedicated team of 7 Scientists and 10 Technicians who are specialized in their respective areas covering assay development, method validation, testing of drug substance and drug product, performed according to cGMP.

The main success criteria for this role are that new analytical methods and equipment in QC are fit for purpose, are implemented in a timely manner and that methods and equipment perform right first time. You should ensure this by leading and scientifically supporting the team within the area of Biochemistry, immunochemistry and molecular biology. You ensure compliance with the quality system and cGMP and take part in decisions around in- and outsourcing of analysis. You develop and optimize relevant assays in cooperation with our sister QC department in Denmark.

Your tasks will include:

  • Supporting, facilitating and driving high priority implementation and development projects in QC;
  • Following up and reporting project progress;
  • Participating in the scientific work in QC. This might include:
    • Maintaining competencies and knowledge in the areas of QC analysis and equipment – including being updated on relevant quality laws, rules and guidelines;
    • Establishing relevant GMP documentation e.g. SOPs, change requests, deviations;
    • Performing scientific review of GMP documents e.g. protocols, validation reports, SOPs etc.
      • Performing data-based analysis as well as statistics to support “right first time” project decisions;
      • Taking part in the scientific development of the department including improve, develop, validate and implement new techniques and assays.
  • Leading a team.

About you

To become a success in this role you have following experience:

  • You have a PhD in Biology, Biochemistry, Microbiology, Pharmacy or equal;
  • You have at least 10 years of experience working with analytical methods/method development;
  • You have min. 5 years experience as leader;
  • You have experience in qualification of analytical equipment (computerized systems);
  • You have experience in cG(x)P;
  • It is an advantage if you have experience with project management tools;
  • You master fluent communication skills in German and English as our corporate language is English and the majority of documentation is written in English.

You are a great facilitator and at the same time you can make decisions. You are analytical but also pragmatic and your way of working is very structured and easy to follow. You are easy to collaborate with and have a good sense of humor.

You will report to the Snr, Director of Global QC.

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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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