* Provide technical and managerial leadership for the QC team in Germany and all aspects of the QC
labs
* Supervision of the heads of Quality Control (as defined in EudraLex Volume 4, Chapter 2) for drug
substance and drug product
* Lead and oversee the QC lab design and setup including validation and qualification activities
* Provide procedures, expertise, and resources for analytical method transfers; collaborate with
transferring internal or external transferring lab
* Continuously improve the QA quality system, processes, and execution, e.g. regarding data
creation, documentation and results
* Create a safety culture, enforce safety measures, and ensure QC staff is working in a safe environment
* Ensure QC staff receives the required GMP training and on-the-job training (for initial on boarding
and ongoing) to maintain compliance and quality of work
* Interact with external and internal customers to provide high quality service
* Maintain QC operating costs within budget
* As member of German leadership teams, actively work with the other leads to resolve site/country issues and help enhancing the collaboration across departments
Your Profile:
* Bachelor, Master, or PhD degree in life science, engineering, or related discipline
* Minimum of 10 years of relevant pharmaceutical/ bio pharmaceutical industry experience, including
CMC process development and GMP manufacturing
* Working knowledge and understanding of current regulations and industry trends for biologics
product development, manufacture, and testing, including cGMP, ICH, Ph. Eur., USP, JP, and other
relevant global compendium and guidance
* Experience in a Contract Research Organisation (CRO) or Contract Manufacturing Organisation
(CMO) is preferable
* Proven track record working in cross-functional teams, on a variety of different technical, business
and operational areas
* Proficiency in German and English is required
