Company

QA Manager (m/f/d)

Heilbronn, Germany, Europe

Company Overview:

ProtaGene is a world-leading analytic CRO partner for the biopharmaceutical and cell and gene therapy industries. From research through product commercialization, we provide the most advanced, integrated, and Quality system driven analytic capabilities and packages for biologic therapeutics as well as cell and gene therapy platforms. Our deep history of analytical leadership in protein-based therapeutics stems from the merger of Protagen Protein Services in Europe and BioAnalytix in the US. In 2021 GeneWerk’s unique capabilities in vector safety, integration site analysis, and bioinformatics were integrated into our platforms and service offerings, establishing ProtaGene. The organization operates over four sites in Europe and North America, and works with leading large pharma, biopharmaceutical, and gene therapy companies worldwide.

Please click here to see the German Translation.

Responsibilities:

  • Maintenance and further development of the quality management system
  • Creation, review and management of QM documents
  • Processing, evaluation and tracking of deviations, changes and CAPA processes
  • Planning, monitoring and implementation of training measures
  • Planning and monitoring of qualification and validation activities
  • Reviews of analytical tests
  • Preparation and management of customer and authority audits as well as self-inspections

Qualifications:

  • Successfully completed degree in pharmacy or natural sciences ­or relevant training with several years of professional experience in the regulated environment of the pharmaceutical industry
  • Sound knowledge and at least 3 years of professional experience in the field of quality management under GMP
  • High quality awareness, process orientation, accuracy, reliability, flexibility and goal-oriented action
  • Focused and thorough approach to work with an eye for both detail and the overall process
  • You like to take responsibility for the processes entrusted to you and pursue the goals set with ambition and concentration
  • Team-oriented and enjoy active communication with colleagues and customers
  • Confident in the use of computer-aided working methods and very good knowledge of German and English

We offer:

  • A motivating working environment in a steadily growing company, as well as responsible and varied activities in the exciting field of drug development.
  • A secure job with individual development and training opportunities
  • Appreciation, openness and respect as well as individual working models
  • Optimal induction and a lively feedback culture
  • Comprehensive health management
  • Regular company and team events

We are looking forward to receiving your complete application documents in English or in German, including a letter of motivation, information on the possible starting date and your salary expectations in one or two PDF files by e-mail to: careers-eu@protagene.com

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