Quality System Expert - Suppliers Qualification
Boost your career with us
Polpharma Biologics is a state-of-the-art biological R&D and manufacturing facility, one of the most modern in Europe. We have a fantastic, international team of experienced experts and dynamic young scientists with common goals and values. Biotechnology is our passion.

Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
You will be responsible for:
  • Developing and reviewing Quality System documentation ensuring compliance with internal and legal requirements
  • Qualification of suppliers using risk-based approach and maintaining supplier quality agreements
  • Providing technical mentorship and resolving quality supply chain issues with suppliers 
  • Evaluating whether suppliers comply to all internal and legal criteria and if they qualify as an approved source
  • Monitoring of supplier quality metrics (supplier performance); number of quality events, delivery failures and other recorded incidents; regular reporting and taking corrective actions if necessary
  • Creating annual schedule for external audits, carrying out external cGMP or for-cause audits of partners or third parties to ensure supplier quality-related operations meet quality system criteria
  • Mentoring and coaching colleagues working with supplier qualification process
  • Proactive recognition and resolution of quality issues
  • Participation in internal and external audits
If you have:
  • University degree in Biology, Chemistry, Pharmacy, Biotechnology or other related
  • At least 5 years of working experience in the pharmaceutical industry, incl. 3 years in Quality Control and/or Quality Assurance of pharmaceutical products
  • Experience and knowledge of cGMP and applicable FDA/EMA regulations in the pharmaceutical industry
  • Knowledge of Quality Management Systems and auditing experience
  • Good interpersonal and communication skills that lead to good cooperation
  • Decision-making and problem solving skills, analytical thinking
  • Willingness to travel (domestic and international)
  • Fluency in spoken and written English
We offer:
  • Private healthcare
  • Life insurance
  • Pension plan above national standards
  • Relocation package
  • Additional free day
  • and more…
Why you should work with us
Contact us