Quality Control Manager Biotechnology (m/f)

Quality Control Manager Biotechnology (m/f)

Our client is a highly innovative and a research-based global pharmaceutical company.

Job Overview

  • Manage work activities and align resources across functional areas to achieve corporate, operational and department goals
  • Responsible for providing quality oversight to the commercial method validation program including performing Quality review and approval of method validation and qualification reports
  • Ensure compliance in the validation life cycle of quality control (QC) methods established as part of a commercial control system
  • Provide technical support for maintenance of analytical control standards used for analytical chemistry QC methods
  • Support method troubleshooting and optimization in support of life cycle management of methods for commercial products
  • Train staff and customers on method validation review, relevant business processes and analytical methodology as appropriate
  • Identify, evaluate and implement process improvements as appropriate
  • Support internal and external audits as required

Your Qualifications / Experience

  • Ph.D. or M.S. degree (preferably in Life Science, Analytical Technologies or other QC relevant area) and many years of relevant experience in the pharmaceutical or biopharmaceutical industry
  • A strong scientific background and in-depth knowledge in protein chemistry, analytical chemistry across a wide range of technologies (HPLC, CE, MS, etc.) is necessary
  • Extensive knowledge and experience in equipment qualification and method validation
  • Excellent knowledge of cGMPs or equivalent regulations and ability to interpret and relate Quality standards for implementation and review
  • Ability to create and manage work plans and timelines and independently manage competing priorities with limited instruction
  • Experience with the management of 2 - 4 direct reports
  • Ability to communicate clearly and professionally both in written and spoken English; knowledge of German at any level is a plus

Additional information

  • Location: Germany
  • Official contract and working visa (also for family)
  • Medical insurance
  • Possibility to get permanent residence permit after two years
  • Full support in relocation to Germany
  • To be considered for this position, please submit your resume to us by e-mail