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Quality Assurance (QA) Expert (m/f/d)

  • ProBioGen AG
  • Herbert-Bayer-Straße 8
  • Work experience
  • Quality Management, Quality Assurance
  • Fulltime
  • Published: 2025-10-22
Quality Assurance (QA) Expert (m/f/d), 1. imageQuality Assurance (QA) Expert (m/f/d), 2. image

Who we are

ProBioGen is an internationally operating biotech company based in Berlin-Weißensee, which has specialized in the development and production of biopharmaceutical active ingredients and vaccines throughout many years of experience.  Furthermore, ProBioGen will be the future operator of the cell and gene therapy production facility at the Berlin Center for Gene and Cell Therapies (BC GCT). Every day, more than 270 employees contribute with their creative and diligent work to the establishment of new therapeutic developments in medicine and groundbreaking innovations worldwide.

Through our research, we support the development of effective and safe medical agents to help improve the cures for diseases such as cancer.

We have been growing steadily since 1994 - become an innovator of tomorrow and apply now!
 

What you create

  • Quality assurance support for construction and implementation projects in GMP-regulated environments, including clean rooms, technical building equipment, production facilities, and software
  • Planning, execution, and documentation of qualification activities (DQ, IQ, OQ, PQ) for facilities, devices, and systems
  • Creation, review, and approval of quality-related documents such as URS, design documentation, risk analyses, test plans, validation plans, and SOPs
  • Ensuring compliance with regulatory requirements (EU-GMP, FDA, ICH, ISO) and providing support during regulatory inspections
  • Evaluation and processing of deviations, change controls, and CAPAs in the project context
  • Close cross-functional collaboration with engineering, production, QC, validation, and external partners
  • Co-design and continuous improvement of processes and standards in the area of qualification and GMP compliance

What you bring along

  • Degree in biotechnology, pharmaceutical technology, engineering, or comparable qualification
  • Several years of experience in a GMP-regulated environment, ideally in quality assurance or validation, with a deep understanding of manufacturing and quality processes (e.g., cell and gene therapy)
  • In-depth knowledge of cleanroom and equipment qualification as well as confident handling of international GMP regulations and their implementation
  • Structured, solution-oriented approach to work with a high degree of precision
  • Excellent communication and documentation skills in German and English

What you can expect

ProSphere. Partnership environment, company events
ProBalance. Flexible workschedule and special vacation days
ProHealth. Yoga, Shiatsu, health days and discounted membership in the Urban Sports Club
ProCare. Technical equipment, laboratory clothing, monitor glasses, company pension plan
ProTaste. Cafeteria with Convini fridge, daily fresh lunch specials and free drinks
ProTalent. Onboarding with mentoring program, innovation days, further training opportunities
 

Whom to ask

Every talent is welcome!
Apply now via our online form! Do you have any questions? I will be happy to help you.