View job here

YOUR CONTRIBUTION

Join our global quality operations team and grow with exciting challenges. With your passion and expertise and together with our international colleagues, you will contribute to achieving our company goals. As a (Senior) Manager Operational Quality Assurance, your responsibilities will include the following tasks:

  • Maintenance and further development of operational Quality Assurance for drug products
  • Organize, monitor, and further develop the deviation and CAPA system, process deviations and CAPAs in Jira, and ensure timely resolution
  • Manage training administration for Therapeutics Operations and maintain document management in Smartsolve
  • Maintain product documentation for process-, transport-, and method validation for drug products
  • Prepare Product Quality Reviews (PQRs) for drug products
  • Support inspections by authorities and customers and present relevant QA activities
  • Serve as subject matter contact for deviations, CAPAs, and training management
  • Act as contact person for internal and external stakeholders 

YOUR PROFILE

  • Completed scientific Studies in Pharmacy, Chemistry or a related field of studies, PhD is an advantage
  • Minimum 5 years of experience in the pharmaceutical industry
  • First leadership experience is a plus, ideally within Quality Assurance
  • Good knowledge of cGMP (EU, FDA), GDP and change control processes
  • Proficiency in Microsoft Office package and database queries as well as electronic QM and SOP systems
  • Knowledge of national and international requirements for drug products and drug product importation mandatory
  • Knowledge national and international requirements for medical devices is a plus
  • Analytical thinking and the ability to understand complex matters
  • Teamoriented, proactive organizational talent
  • Strong communication and problem-solving skills with a confident appearance
  • Excellent verbal and written communication skills in German and English 

YOUR BENEFITS

  • Individual career development in a purposeful job: you improve the quality of life of our patients!
  • Hybrid work model that allows a good work-life balance
  • Attractive location with good transport links, modern workplaces and a company restaurant
  • Global family business with flat hierarchies and an open, respectful corporate culture
  • Attractive remuneration with extensive social benefits
  • Variety of employer-subsidized benefits such as WellPass, Deutschland-Ticket, Corporate Benefits and JobBike

Find out more about our benefits here.

 

 

 

Ansprechpartner

David Brodkorb