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Clinical QA Manager

Clinical QA Manager
Amsterdam
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!
Your responsibilities:
  • Risk based audit planning for vendors and clinical sites;
  • Essential, pro-active contribution to development, continuous improvement and maintenance of the Clinical Quality Management System;
  • Reviewing and approval of clinical SOPs to ensure compliance with international standards;
  • Contributing to clinical program design and execution according to internal SOPs and international standards and providing appropriate Quality input and guidance;
  • Defining and supporting implementation of documentation standards for record-keeping and archiving for clinical documentation (both paper and electronic);
  • Implementing measures for oversight and monitoring of clinical vendors according GCP requirements, including CROs and bioanalytical laboratories;
  • Performing Quality reviews of TMFs and other essential clinical documents;
  • Managing clinical non-compliances and acting as a contact person for Quality issues in clinical development;
  • Support the Compliance & Inspection Readiness team to establish and prioritize audit programs for clinical studies;
  • Support the clinical team to identify root-causes and ensure the  implementation of CAPAs;
  • Assisting in preparation, reviewing and approval of regulatory filings (such as: INDs, BLAs, Annual Reports);
  • Supporting and contributing to major Health Authority inspections, in close alignment with the Compliance & Inspection Readiness team;
  • Defining Quality related training needs for the clinical development area, supporting and reviewing training plans and monitoring the timely execution, organizing and conducting GCP related training modules.
If you have:
  • Master’s or PhD degree in a relevant field (medicines, pharmacy, biotechnology, biochemistry, chemistry); 
  • Over 5 years of experience in clinical R&D (Clinical Operations and/or Clinical Quality Assurance), including vendor management;
  • Proven experience in risk based approaches;
  • Experience with GCP inspections;
  • Excellent knowledge of ICH GCP guidelines, EMA, FDA and other relevant regulations
  • Excellent computer skills and understanding of IT landscapes used in clinical studies;
  • Strong skills and willingness to work and communicate cross-functionally;
  • Ability to work adapt to the company and local culture;
  • Very good command of English language, knowledge of or willingness to learn Polish would be an advantage.

 

Why you should work with us
Contact us
career@polpharmabiologics.com

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