Clinical QA Manager
Warszawa
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!
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.